Label: ICY HOT ADVANCED RELIEF- menthol topical analgesic patch
- NDC Code(s): 41167-0805-0, 41167-0805-1
- Packager: Chattem, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 29, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
■ on wounds, damaged, broken or irritated skin
■ with a heating pad or apply local heat to the area of use
When using this product
■ use only as directed
■ do not bandage tightly
■ avoid contact with eyes and mucous membranes
■ 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
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
■ severe burning sensation, redness or irritation develop
■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
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Directions
adults and children 12 years of age and older:
■ 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
children under 12 years of age: consult a doctor
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ICY HOT ADVANCED RELIEF
menthol topical analgesic patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0805 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 210 mg Inactive Ingredients Ingredient Name Strength HYDRATED SILICA (UNII: Y6O7T4G8P9) MINERAL OIL (UNII: T5L8T28FGP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) GLYCEROL ESTER OF HYDROGENATED ROSIN (UNII: XH62RP786N) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41167-0805-0 1 in 1 CARTON 12/01/2012 03/31/2017 1 4 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:41167-0805-1 5 in 1 CARTON; Type 0: Not a Combination Product 10/22/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/01/2012 Labeler - Chattem, Inc. (003336013)