EXTRA STRENGTH PAIN RELIEF THERAPY  - menthol patch 
United Exchange Corp

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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Drug Facts

Active ingredient                                                                       Purpose

Menthol 5%.................................................................Topical analgesic

Uses Temporary relieves minor pain associated with:

Warnings For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.

If pregnant or breast-feeding, ask a health professional before use.

Directions

Other information

Inactive ingredients aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non woven fabric.

Distributed by:

United Exchange Corp

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image of carton label
EXTRA STRENGTH PAIN RELIEF THERAPY  
menthol patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-701
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 750 mg
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65923-701-05 5 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/30/2013
Labeler - United Exchange Corp (840130579)

Revised: 6/2013
Document Id: dc5263cb-36f2-4900-a769-4804b5b35b60
Set id: e024aaaf-f615-4b7a-99af-cbdafd05c420
Version: 4
Effective Time: 20130630
 
United Exchange Corp