Label: ROCKSAUCE FIERY HOT PAIN RELIEF- methyl salicylate, menthol, capsaicin cream
- NDC Code(s): 81683-025-01
- Packager: Implus Footcare, LLC
- 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 September 21, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES:
- WARNINGS:
- When using this product, do not:
- DO NOT USE
- ASK DOCTOR
- Keep out of reach of children:
- DIRECTIONS:
-
INACTIVE INGREDIENTS:
Aminomethyl Propanol, Aloe Barbadensis(Aloe Vera)Leaf Juice, Arnica Montana Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Propylene Glycol, Potassium Cetyl Phosphate, Tocopheryl Acetate, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROCKSAUCE FIERY HOT PAIN RELIEF
methyl salicylate, menthol, capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81683-025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.25 g in 2.45 mL CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.00005 g in 2.45 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.5 g in 2.45 mL Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MALTODEXTRIN (UNII: 7CVR7L4A2D) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81683-025-01 2.45 mL in 1 POUCH; Type 0: Not a Combination Product 09/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/21/2021 Labeler - Implus Footcare, LLC (361531585)