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| Product NDC Code | 62168-0856 | ||||
|---|---|---|---|---|---|
| Drug Name | Icy hot medicated, back |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | PATCH | ||||
| RxCUI drug identifier | 420222 | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Lead Chemical Co., Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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 for up to 8 hours ▪ repeat as necessary, but no more than 3 times daily children 12 years or younger: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
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
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, 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
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 - Large Patch (6 Patch Pouch) MENTHOL 5% ICY HOT ® ORIGINAL Pain Relief Patch LARGE 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 6 Patches in 1 Resealable Pouch 3-15/16” x 7-13/16” (10 cm x 20 cm) each CHATTEM ® Dist. by Chattem, Inc., a Sanofi Company P.O. Box 2219 Chattanooga, TN 37409-0219 USA ©2020 www.icyhot.com Made in Japan Pouch Label image-01
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 ▪ 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
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 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
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 When using this product ▪ 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 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.
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