PAIN GOODBYE MEDICATED CREAM- menthol 5% cream
Austin Biotechnology Inc

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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PAIN GOODBYE MEDICATED CREAM

ACTIVE INGREDIENTS

Menthol 5%

PURPOSE

Menthol External Analgesic

USES

Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis and strains.

WARNINGS

Use only as directed. For External Use Only. Avoid contact with eyes, mucous membrances, rashes, wounds or damaged skin. Package not child resistent, in case of accidental ingestion, contact doctor immediately.

WARNINGS

Keep out of reach of children.

WARNINGS

Do not apply on nose and genital area. If rashes, redness and itchness result, discontinue use and consult a doctor.

WARNINGS

If prone to allergic reaction to the product, consult a doctor before using.

DIRECTION

Adult and children 12 years of age and older; apply a few drops to affected area and rub gently 3 to 4 times daily. Children under age of 12, do not use, consult a doctor.

INACTIVE INGREDIENTS

Peppermint Oil, Eucolyptus Oil, Lavendor Oil, Clove oil, Jasmine Lactone, Stearic Acid, Glyceryl monostearate, Carbomer

PAIN GOODBYE MEDICATED CREAM
menthol 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:15667-5049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	14 g in 280 g

Ingredient Name	Strength
Inactive Ingredients
PEPPERMINT OIL (UNII: AV092KU4JH)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
JASMINE LACTONE (UNII: H8558L43SR)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CARBOMER 1342 (UNII: 809Y72KV36)
CLOVE OIL (UNII: 578389D6D0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:15667-5049-4	280 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/26/2011

Labeler - Austin Biotechnology Inc (656001949)

Registrant - Austin Biotechnology Inc (656001949)

Name	Address	ID/FEI	Business Operations
Establishment
Austin Biotechnology Inc		656001949	manufacture(15667-5049)