MUSCLE RUB (PAIN RELIEVE) CREAM [AFN BROKER LLC]

MUSCLE RUB (PAIN RELIEVE) CREAM [AFN BROKER LLC]
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NDC	72004-002-35
Set ID	6b4faec1-fded-546a-e053-2991aa0a44bd
Category	HUMAN OTC DRUG LABEL
Packager	AFN BROKER LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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DRUG FACTS

ACTIVE INGREDIENTS

ASK A DOCTOR BEFORE USE

DO NOT USE

INACTIVE INGREDIENTS

KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL INGESTION

STOP USE AND ASK A DOCTOR IF

USES

WARNINGS

WHEN USING THIS PRODUCT

STORAGE

PURPOSE

DIRECTIONS

INGREDIENTS AND APPEARANCE

MUSCLE RUB
pain relieve cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72004-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.3 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)	MENTHOL	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72004-002-35	35 g in 1 JAR; Type 0: Not a Combination Product	08/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/01/2018

Labeler - AFN BROKER LLC (030117252)

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