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| Product NDC Code | 41167-0854 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot value pack |
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| Type | Brand | ||||
| Route | TOPICAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Menthol 5%
Active Ingredient Menthol 5%
Active Ingredient Menthol 5%
Active Ingredient Menthol 5%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions adults and children over 12 years. remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area wear one Icy Hot Patch up to 8 hours repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor
Directions adults and children over 12 years. remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area wear one Icy Hot Patch up to 8 hours repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor
Directions adults and children over 12 years. remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area wear one Icy Hot Patch up to 8 hours repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor
Directions adults and children 12 years of age and older: remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area apply to affected area not more than 3 to 4 times daily wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive I ngredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch BACK & LARGE AREAS
Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch XL BACK & LARGE AREAS
Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT. Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan. Icy Hot® - Medicated Patch Value Pack
Inactive Ingredients aluminum hydroxide, cellulose gum, glycerin, isopropyl myristate, methyl acrylate/2-ethylhexyl acrylate copolymer, nonoxynol-30, polyacrylic acid, polysorbate 80, sodium polyacrylate, sorbitan sesquioleate, starch/acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION Distributed by Chattem, Inc. P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2024 Made in Japan.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps
Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps
Uses temporarily relieves minor pain associated with: arthritis simple backache bursitis tendonitis muscle strains sprains bruises cramps
Uses temporarily relieves minor pain associated with: arthritis simple backache strains sprains bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Purpose Topical analgesic
Purpose Topical analgesic
Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Arm Neck Leg and Small Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Back and Large Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot XL Back and Large Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Back and Large Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Back and Large Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER ICY Hot Value Pack Menthol Icy Hot Arm Neck Leg and Small Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Back and Large Areas Menthol MENTHOL MENTHOL ALUMINUM HYDROXIDE CELLULOSE GUM GLYCERIN ISOPROPYL MYRISTATE METHYL ACRYLATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE STARCH, CORN ACRYLIC ACID TALC TARTARIC ACID TITANIUM DIOXIDE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel ICY HOT ® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours Small Patch 3-1/8” x 4-5/8” (8 cm x 12 cm) each ARM. NECK & LEG PATCH Contains 5 Patches in 1 Resealable Pouch ICY HOT® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours Small Patch 3-1/8” x 4-5/8” (8 cm x 12 cm) each ARM. NECK & LEG PATCH Contains 5 Patches in 1 Resealable Pouch
Principal Display Panel ICY HOT ® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours LARGE PATCH 3-15/16 ” x 7-13/16 ” ( 10 cm x 20 cm) each Contains 5 Patches I n 1 Resealable Pouch Principal Display Panel ICY HOT® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours LARGE PATCH 3-15/16” x 7-13/16” (10 cm x 20 cm) each Contains 5 Patches In 1 Resealable Pouch
Principal Display Panel ICY HOT ® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours XL PATCH 5-1 / 2 ” x 9 -3/ 4 ” (1 4 cm x 2 5 cm) each Contains 3 Patches In 1 Resealable Pouch Principal Display Panel ICY HOT® ORIGINAL Pain Relief Patch Menthol 5% ICY to DULL, HOT to RELAX Wear for up to 8 Hours XL PATCH 5-1/2” x 9-3/4” (14 cm x 25 cm) each Contains 3 Patches In 1 Resealable Pouch
Principal Display Panel ICY HOT ® ORIGINAL Pain Relief Patch Principal Display Panel ICY HOT® ORIGINAL Pain Relief Patch
Principal Display Panel ICY HOT ® ORIGINAL Pain Relief Patch Menthol 5% Principal Display Panel ICY HOT® ORIGINAL Pain Relief Patch Menthol 5%
Principal Display Panel ICY HOT ORIGINAL PATCH PAIN RELIEF 5 % MENTHOL ASSORTED SIZES 10 PATCHES ICY HOT ORIGINAL PATCH PAIN RELIEF 5 % MENTHOL ASSORTED SIZES 10 PATCHES
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Icy Hot ® - Medicated Patch ARM, NECK & LEG & SMALL AREAS
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days
When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days
When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days
When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding ask a health professional before use.
If pregnant or breast-feeding ask a health professional before use.
If pregnant or breast-feeding ask a health professional before use.
If pregnant or breast-feeding ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only When using this product use only as directed. Read and follow all directions and warnings on this carton. avoid contact with eyes and mucous membranes rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged skin, broken or irritated skin do not bandage tightly or apply local heat (such as heating pads) to the area of use a transient burning sensation may occur upon application but generally disappears in several days Stop use and ask a doctor if condition worsens redness is present irritation develops symptoms persist for more than 7 days or clear up and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings For external use only Do not use ■ on wounds or on irritated or damaged skin ■ with a heating pad When using this product ■ use only as directed ■ do not bandage tightly ■ avoid contact with eyes and mucous membranes ■ do not expose the area to local heat or to direct sunlight ■ rare cases of serious burns have been reported with products of this type ■ a transient burning sensation may occur upon application but generally disappears in several days ■ avoid applying into skin folds Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days symptoms clear up and occur again within a few days redness is present or excessive skin irritation occurs you experience severe burning pain, swelling, or blistering where the product was applied If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API