Label: ICEQUAKE COLD HOT- menthol patch
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Contains inactivated NDC Code(s)
NDC Code(s): 69822-010-04 - Packager: Southern Sales & Service, 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 11, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- WARNINGS
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Aluminium glycinate,1,3-buthylene Glycol, Carboxymethylcellulose Sodium, Concentrated Glycerin, diethylene Glycolmonoethyl Ether, Disodium Edetate, Methyl Parahydroxybenzoate, Polyacrylic Acid Solution, Polysorbate 80, Propyl Parahydroxybenzoate, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Oxide
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PURPOSE
- When using this product
- Stop use and ask a doctor
- KEEP OUT OF REACH OF CHILDREN
- If pregnant or breastfeeding
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ICEQUAKE COLD HOT
menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-010 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) DIETHYLENE GLYCOL (UNII: 61BR964293) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) METHYLPARABEN (UNII: A2I8C7HI9T) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69822-010-04 4 in 1 BOX 03/01/2019 1 9 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 03/01/2019 Labeler - Southern Sales & Service, Inc. (013114906)