Label: RITE AID HOT AND COLD ROLL ON- menthol 16% liquid
- NDC Code(s): 11822-1015-1
- Packager: Rite Aid
- 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 May 22, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Flammable--keep away from fire or flame.
For external use only.
When using this product keep out of eyes, do not apply to wounds or damaged skin, do not bandage tightly.
Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days, and redness or irritation develops.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RITE AID HOT AND COLD ROLL ON
menthol 16% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1015 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 PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) XANTHAN GUM (UNII: TTV12P4NEE) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1015-1 1 in 1 CARTON 05/22/2023 1 71 g in 1 BOTTLE, PLASTIC; 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 05/22/2023 Labeler - Rite Aid (014578892) Registrant - Derma Care Research Labs, LLC (116817470) Establishment Name Address ID/FEI Business Operations Derma Care Research Labs, LLC 116817470 manufacture(11822-1015)