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| Product NDC Code | 62168-0847 | ||||||||
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| Drug Name | Icy hot medicated, xl |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | PATCH | ||||||||
| RxCUI drug identifier | 420222, 1010823 |
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| Application Number | 505G(a)(3) | ||||||||
| Labeler Name | Lead Chemical Co., Ltd. | ||||||||
| 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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches Menthol 5% Icy Hot Advanced Relief Patches Menthol 7.5%
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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches 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 for up to 8 hours ▪ repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor Icy Hot Advanced Relief Patches adults and children 12 years of age and older: ▪ clean and dry affected area ▪ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain. ▪ remove remaining film backing from both sides and finish applying to skin ▪ 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 ingredients Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches 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 Icy Hot Advanced Relief Patches glyceryl hydrogenated rosinate, mineral oil, polyisobutene, styrene/isoprene copolymer
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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches temporarily relieves minor pain associated with: ▪ arthritis ▪ simple backache ▪ bursitis ▪ tendonitis ▪ muscle strains ▪ sprains ▪ bruises ▪ cramps Icy Hot Advanced Relief Patches temporarily relieves minor aches and pains of muscles and joints associated with: ▪ arthritis ▪ simple backache ▪ strains ▪ sprains ▪ bruises
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Icy Hot Medicated Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN ISOPROPYL MYRISTATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Medicated, Back Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN ISOPROPYL MYRISTATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Medicated, XL Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM ALUMINUM HYDROXIDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM GLYCERIN ISOPROPYL MYRISTATE NONOXYNOL-30 POLYACRYLIC ACID (250000 MW) POLYSORBATE 80 SODIUM POLYACRYLATE (2500000 MW) SORBITAN SESQUIOLEATE TALC TARTARIC ACID TITANIUM DIOXIDE WATER Icy Hot Medicated, Advanced Relief Menthol MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM MINERAL OIL POLYISOBUTYLENE (1000 MW)
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 - Arm, Neck & Leg Pouch MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch ARM, NECK & LEG PATCH FEEL IT WORKING INSTANTLY ➢ Powerful Targeted Relief ➢ Icy to Dull, Hot to Relax ➢ Comfortable Fabric ➢ Stays in Place Wear For Up To 8 Hours Contains 5 Patches in 1 Resealable Pouch 3-1/8" x 4-5/8" (8 cm x 12 cm) each CHATTEM ® A SANOFI COMPANY Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Pouch Label - Arm, Neck, & Leg Pouch Label – Arm, Neck, & Leg
Principal Display Panel – Extra Strength Back and Large Areas ICY HOT ® MEDICATED PATCH Menthol 5% BONUS 20% MORE! one free patch inside TARGETED NO MESS RELIEF • Stops Pain at the Source • Lasts up to 8 Hours • Comfortable Fabric Stays in Place Pain Relieving Ointment on a Breathable Adhesive Pad EXTRA STRENGTH BACK and Large Areas Contains 6 Patches in 1 Resealable Pouch 3-15/16” x 7-13/16” (10 cm x 20 cm) each CHATTEM ® A SANOFI COMPANY Distributed by Chattem, Inc., P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2017 www.icyhot.com Pouch Label - Back and Large Areas – Bonus Pouch Label - Back and Large Areas – Bonus
Principal Display Panel - XL Back MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch XL PATCH FEEL IT WORKING INSTANTLY ➢ Powerful Targeted Relief ➢ Icy to Dull, Hot to Relax ➢ Comfortable Fabric ➢ Stays in Place Wear For Up To 8 Hours Contains 3 Patches in 1 Resealable Pouch 5-1/2" x 9-3/4" (14 cm x 25 cm) each CHATTEM ® A SANOFI COMPANY Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Pouch Label - XL Back Pouch Label - XL Back
Principal Display Panel - Extra Strength XL Back and Large Areas MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch XL PATCH FEEL IT WORKING INSTANTLY ➢ Powerful Targeted Relief ➢ Icy to Dull, Hot to Relax ➢ Comfortable Fabric ➢ Stays in Place Wear For Up To 8 Hours Contains 4 Patches in 1 Resealable Pouch 5-1/2" x 9-3/4" (14 cm x 25 cm) each CHATTEM ® A SANOFI COMPANY Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Pouch Label - XL Back – Bonus image-06
Principal Display Panel - Advanced Pain Relief Patch MENTHOL 7.5% ICY HOT ® ADVANCED Pain Relief Patch LARGE PATCH MORE PAIN FIGHTING INGREDIENTS* ➢ Fast Acting Powerful Relief ➢ Comfortable Fabric ➢ Stays in Place Wear For Up To 8 Hours Contains 5 Patches in 1 Resealable Pouch 3-15/16" x 5-1/2" (10 cm x 14 cm) each *Per same size patch vs Icy Hot ® original strength patch Dist. by: Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2021 www.icyhot.com Pouch Label - Advanced Pain Relief Patch image-08
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Icy Hot Advanced Relief Patches ▪ on wounds or on irritated or damaged skin ▪ with a heating pad
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.
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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches ▪ 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 Icy Hot Advanced Relief Patches ▪ 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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches ▪ use only as directed. Read and follow all directions and warnings on this label. ▪ 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, 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 Icy Hot Advanced Relief Patches ▪ 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.
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 Do not use Icy Hot Advanced Relief Patches ▪ on wounds or on irritated or damaged skin ▪ with a heating pad When using this product Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches ▪ use only as directed. Read and follow all directions and warnings on this label. ▪ 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, 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 Icy Hot Advanced Relief Patches ▪ 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 Icy Hot Arm, Neck and Leg Patches; Icy Hot Back Patches; and Icy Hot XL Patches ▪ 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 Icy Hot Advanced Relief Patches ▪ 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