PAIN GOODBYE AQUEOUS PATCH- methyl salicylate patch 
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 AQUEOUS BALM PATCH

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

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PAIN GOODBYE AQUEOUS PATCH 
methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15667-7396
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 mg  in 1000 mg
2-(L-MENTHOXY)ETHANOL (UNII: 5ZWW23169H) (2-(L-MENTHOXY)ETHANOL - UNII:5ZWW23169H) 2-(L-MENTHOXY)ETHANOL80 mg  in 1000 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
MYRRH (UNII: JC71GJ1F3L)  
SESAME OIL (UNII: QX10HYY4QV)  
WATER (UNII: 059QF0KO0R)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15667-7396-55 in 1 BAG
1NDC:15667-7396-31000 mg in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/26/2011
Labeler - Austin Biotechnology Inc (656001949)
Registrant - Austin Biotechnology Inc (656001949)
Establishment
NameAddressID/FEIBusiness Operations
Austin Biotechnology Inc656001949manufacture(15667-7396)

Revised: 10/2013
Document Id: 8c3ae600-4511-4868-a9bd-848f707e7f87
Set id: 0e8b325d-4b41-4f9f-a778-b9b5d1c8525f
Version: 2986
Effective Time: 20131010
 
Austin Biotechnology Inc