PAIN GOODBYE MEDICATED CREAM- menthol 5% cream

PAIN GOODBYE MEDICATED CREAM by

Drug Labeling and Warnings

PAIN GOODBYE MEDICATED CREAM by is a Otc medication manufactured, distributed, or labeled by Austin Biotechnology Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN GOODBYE MEDICATED CREAM 
menthol 5% cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Austin Biotechnology Inc (656001949)

Registrant - Austin Biotechnology Inc (656001949)

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