FAMILY CARE BACK PAIN THERAPY (camphor- synthetic, menthol, and capsicum oleoresin patch

FAMILY CARE BACK PAIN THERAPY by

Drug Labeling and Warnings

FAMILY CARE BACK PAIN THERAPY by is a Otc medication manufactured, distributed, or labeled by UNITED EXCHANGE CORP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 80mg / patch	Topical Analgesic
Menthol 24mg / patch	Topical Analgesic
Capsicum Extract 16mg / patch	Topical Analgesic

PURPOSE

Uses

For temporary relief of pains.

WARNINGS

Warnings

FOR EXTERNAL USE ONLY

WHEN USING

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

Stop use and ask a doctor if

• Condition worsens
• Severe skin irritation occurs
• Pain persists for more than 7 days

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

STORAGE AND HANDLING

Other Information

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Distributed By:

UNITED EXCHANGE CORP.

17211 VALLEY VIEW AVE.

CERRITOS, CA 90703

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE BACK PAIN THERAPY 
camphor (synthetic), menthol, and capsicum oleoresin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	80 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	24 mg
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM OLEORESIN - UNII:UW86K581WY)	CAPSICUM OLEORESIN	16 mg

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (UNII: 532B59J990)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-901-37	1 in 1 BOX
1		2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/27/2011

Labeler - UNITED EXCHANGE CORP (840130579)