Label: QC COOL AND HEAT ROLL-ON- menthol 16% liquid
- NDC Code(s): 63868-511-02
- Packager: Chain Drug Marketing Association Inc
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated January 9, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QC COOL AND HEAT ROLL-ON
menthol 16% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-511 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 16 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-511-02 71 g in 1 BOTTLE; Type 0: Not a Combination Product 12/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 12/16/2021 Labeler - Chain Drug Marketing Association Inc (011920774) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(63868-511)