MUSCLE RUB- pain relieve cream 
AFN BROKER LLC

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.

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DRUG FACTS

ACTIVE INGREDIENTS

ACTIVE INGREDIENTS

ASK A DOCTOR BEFORE USE

ASK A DOCTOR BEFORE USE

DIRECTIONS

DO NOT USE

DO NOT USE

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS

KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION

KEEP OUT

STOP USE AND ASK A DOCTOR IF

STOP USE

USES

USES

WARNINGS

WARNINGS

WHEN USING THIS PRODUCT

WHEN USING THIS PRODUCT

USE

STORAGE

STORAGE

PURPOSE

PURPOSE

DIRECTIONS

DIRECTION

MUSCLE RUB 
pain relieve cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72004-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.3 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.04 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCOL STEARATE SE (UNII: 6YLY96TQL6) 0.025 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.02 g  in 100 g
ACETYLATED LANOLIN (UNII: 2X654GD19H) 0.05 g  in 100 g
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) 0.008 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.1 g  in 100 g
WATER (UNII: 059QF0KO0R) 0.264 g  in 100 g
STEARIC ACID (UNII: 4ELV7Z65AP) 0.08 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.75 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72004-002-3535 g in 1 JAR; Type 0: Not a Combination Product08/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2018
Labeler - AFN BROKER LLC (030117252)

Revised: 1/2019
Document Id: 7f1e9bdf-cd80-272f-e053-2a91aa0aabf4
Set id: 6b4faec1-fded-546a-e053-2991aa0a44bd
Version: 2
Effective Time: 20190110
 
AFN BROKER LLC