ROCKSAUCE FIERY HOT PAIN RELIEF- methyl salicylate, menthol, capsaicin cream

RockSauce FIERY HOT PAIN RELIEF by

Drug Labeling and Warnings

RockSauce FIERY HOT PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Implus Footcare, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl Salicylate 20%

Menthol 10%

Capsaicin0.002%

PURPOSE

Topical Analgesic

USES:

Provides soothing heat to sore muscles and joints.

WARNINGS:

For external use only. Avoid contact with eyes, mucous membrane or broken skin.

When using this product, do not:

heat, microwave, add to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrane, take by mouth or place in nostrils, apply to wounds or damaged skin.

DO NOT USE

Do not use otherwise than as directed.

ASK DOCTOR

Consult a doctor and discontinue use if irritation occurs.

Ask a health professional before use if pregnant or breastfeeding.

Ask a doctor before using if you have sensitive skin.

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 68° to 77 ℉(20° to 25℃).

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

INGREDIENTS AND APPEARANCE

ROCKSAUCE FIERY HOT PAIN RELIEF 
methyl salicylate, menthol, capsaicin cream

Product 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)