ROCKSAUCE COOLING MASSAGE- menthol, methyl salicylate cream

RockSauce Cooling Massage by

Drug Labeling and Warnings

RockSauce Cooling Massage by is a Otc medication manufactured, distributed, or labeled by Implus Footcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENT

Menthol 10%

Methyl Salicylate 20%

PURPOSE

Topical Analgesic

USES:

Provides soothing heat to sore muscles and joints.

WARNINGS:

For external use only.

When using this product,

do not take by mouth or place in nostrils, apply to wounds or damaged skin. Use as directed.

Ask a health professional before use if you have

sensitive skin or are pregnant or breastfeeding, Discontinue use if irritation occurs.

Keep out of reach of children.

In case of accidental ingestion, get medical help or call Poison Control Center right away. Not for children 5 years or younger.

DIRECTIONS:

Apply liberally to area of pain and massage until lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68º to 77ºF (20º to 25ºC)

INACTIVE INGREDIENTS:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, ARNICA MONTANA FLOWER EXTRACT, CAPSAICIN, CETEARYL ALCOHOL, MALTODEXTRIN, PHENOXYETHANOL, PHENOXYETHANOL ETHYLHEXYLGLYCERIN, POTASSIUM CETYL PHOSPHATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, WATER

Package Labeling:

INGREDIENTS AND APPEARANCE

ROCKSAUCE COOLING MASSAGE 
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81683-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAPSAICIN (UNII: S07O44R1ZM)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81683-007-01	1 in 1 BOX	05/01/2025
1		354.8 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/01/2025

Labeler - Implus Footcare, LLC (361531585)

Registrant - Implus Footcare, LLC (361531585)