NDC | 65923-901-37 |
Set ID | e3f69b3d-9376-41d6-bc63-a0f5ffc4ad91 |
Category | HUMAN OTC DRUG LABEL |
Packager | UNITED EXCHANGE CORP |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
-
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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FAMILY CARE BACK PAIN THERAPY
camphor (synthetic), menthol, and capsicum oleoresin patchProduct 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)