ROCKSAUCE WARMING MASSAGE ROLL-ON- menthol, methyl salicylate cream, augmented

RockSauce Warming Massage Roll-On by

Drug Labeling and Warnings

RockSauce Warming Massage Roll-On 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 pace in  nostrils, apply to wounds or damaged skin. Use as directed. 

Ask a health professional before use 

if you have senstive 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 youger.

DIRECTIONS:

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

Inactive Ingredients NDC: ​81683-005-01

2-ETHYLHEXYL PALAMITATE, ALOE BARBADENSIS LEAF JUICE, CAPSAICIN, CARBOMER, CETEARYL ALCOHOL, DIMETHYL SILICONE OIL, METHYLPARABEN, PHENOXYETHANOL, PORTULACA OLERACEA EXTRACT, PROPYL GLYCOL, PROPYLPARABEN, SPAN 60, TRIETHANOLAMINE, TWEEN 60, WATER

Inactive Ingredients NDC:

81683-005-02

Acrylates/C10-30 alkyl acrylate crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl propanol, Arnica Montana Flower Extract, Capsaicin, Cetearyl Alcohol, Ethylhexylglycerin, Maltodextrin, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Tocopheryl Acetate, Water

81683-005-01

81683-005-02

INGREDIENTS AND APPEARANCE

ROCKSAUCE WARMING MASSAGE ROLL-ON 
menthol, methyl salicylate cream, augmented

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81683-005
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	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
CAPSAICIN (UNII: S07O44R1ZM)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PURSLANE (UNII: M6S840WXG5)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81683-005-01	1 in 1 BOX	05/01/2025
1		49.3 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 81683-005-02	1 in 1 BOX	05/01/2025
2		88.5 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)