FAMILY CARE THERA FLEX PAIN  - capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide 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 ingredients (in each patch)                                                                                           Purpose

Capsaicin 0.0056%...............................................................................................................Topical analgesic

DL-Camphor 1.48%...............................................................................................................Topical analgesic

L-Menthol 3.95%...................................................................................................................Topical analgesic

Methyl salicylate 3.95%.........................................................................................................Topical analgesic

Peppermint oil 1.95%.............................................................................................................Skin protectant

Zinc oxide 18.77%.................................................................................................................Skin protectant

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:

Warnings   For external use only

When using this product

Stop use and ask a doctor if

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

Keep out of reach of children.

Do not use on infants.  If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

adults and children over 12 years:

children 12 years or younger:

Other information

Inactive ingredients

butylated hydroxytoluene, calcium carbonate, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, terpene resin

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image of carton label

FAMILY CARE THERA FLEX PAIN  
capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0056 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.48 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.95 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE3.95 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL1.95 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.77 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-100-101 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/30/2012
Labeler - UNITED EXCHANGE CORP (840130579)

Revised: 9/2012
Document Id: 9b3d09c8-60c7-41e2-a500-30f72194f73d
Set id: 85171b3e-01f6-49d0-b313-1b6e939fcadd
Version: 1
Effective Time: 20120930
 
UNITED EXCHANGE CORP