FAMILY CARE BACK PAIN THERAPY

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 80mg, MENTHOL 24mg, CAPSICUM OLEORESIN 16mg
Labeler: UNITED EXCHANGE CORP
NDC Code: 65923-901

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.

Drug Facts

Active IngredientsPurpose
Camphor 80mg / patchTopical Analgesic
Menthol 24mg / patchTopical Analgesic
Capsicum Extract 16mg / patchTopical Analgesic

Uses

For temporary relief of pains.

Warnings

FOR EXTERNAL USE ONLY

When using this product
  • Use only as directed
  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use 1 hour prior to bathing or 30 minutes after bathing

Stop use and ask a doctor if
  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than 7 days


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


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

Directions
  • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years, consult doctor before use
  • How to apply:
    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

Other Information

This product may cause allergic reaction in some individuals. Store in cool dry place away from direct sunlight.

Inactive Ingredients

Aluminium glycinate, eucalyptus oil, glycerin, kaolin, mentha oil, polysorbate 80, propylene glycol, sodium carboxymethylcellulose, sodium polyacrylate, polyacrylic acid solution, sorbitol solution, hydrotalcite, water

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703


MADE IN KOREA

FAMILY CARE BACK PAIN THERAPY 
camphor (synthetic), menthol, and capsicum oleoresin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-901
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)80 mg
MENTHOL (MENTHOL) MENTHOL24 mg
CAPSICUM OLEORESIN (CAPSICUM OLEORESIN) CAPSICUM OLEORESIN16 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
CARBOXYMETHYLCELLULOSE SODIUM 
EDETATE DISODIUM 
EUCALYPTUS OIL 
ISOPROPYL MYRISTATE 
KAOLIN 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
POLYSORBATE 80 
POLYVINYL ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:65923-901-371 PACKET (PACKET) in 1 BOX
12 PATCH (PATCH) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/27/2011
Labeler - UNITED EXCHANGE CORP (840130579)

Revised: 12/2011
 
UNITED EXCHANGE CORP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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