PAIN GOODBYE AQUEOUS PATCH- methyl salicylate patch

PAIN GOODBYE AQUEOUS PATCH by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

Methyl Salicylate   50 mg

L-Methenol            80 mg

PURPOSE

Methyl Salucylate   External Analgesic

L-Methenol             External Analgesic

USES

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

WARNINGS

For External Use Only. Do not use on wounds, on infected or damaged skin.

Stop use and ask a doctor if

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

Stop use and ask a doctor if

Condition worsens.

Symptom clears up and occurs again within a few days.

Symptom persists for more than 7 days.

Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs.

Excessive irritation of the skin develops.

Stop use and ask a doctor if

Avoid contact with eyes or mucous membranes.

Do not bandage tightly.

When using for pain of arthritis:

In conditions affecting children under 12 years of age

If red nose is present

If pain persists for more than 10 days

WARNINGS

For children under 12 years of age, do not  use, consult a doctor.

Directions

Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily.

Bandage will remain effective after 24 hours and will be even more effective when using after a bath.

Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal.

Other Information:

Keep container tightly closed. Once opened, fold the opening and keep pressed. Close with a clip.

Store at room temperature.

INACTIVE INGREDIENTS

Gelatin, Myrrhm, Sesame Oil, Water and Zinc Oxide

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN GOODBYE AQUEOUS PATCH 
methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15667-7396
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	50 mg  in 1000 mg
2-(L-MENTHOXY)ETHANOL (UNII: 5ZWW23169H) (2-(L-MENTHOXY)ETHANOL - UNII:5ZWW23169H)	2-(L-MENTHOXY)ETHANOL	80 mg  in 1000 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
MYRRH (UNII: JC71GJ1F3L)
SESAME OIL (UNII: QX10HYY4QV)
WATER (UNII: 059QF0KO0R)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15667-7396-5	5 in 1 BAG
1	NDC: 15667-7396-3	1000 mg in 1 BAG

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(15667-7396)