FAMILY CARE THERA FLEX PAIN- capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch

FAMILY CARE THERA FLEX PAIN by

Drug Labeling and Warnings

FAMILY CARE THERA FLEX PAIN 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 (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

PURPOSE

Uses

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

• strains
• sprains
• simple backache
• arthritis
• bruises
  

WARNINGS

Warnings   For external use only

WHEN USING

When using this product

• use only as directed
• do not bandage tightly or use with heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds or damaged skin
  

STOP USE

Stop use and ask a doctor if

• conditions worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
  

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

INDICATIONS & USAGE

Directions

adults and children over 12 years:

• carefully remove backing from patch
• apply sticky side of patch to affected area
• repeat as necessary, but no more than 4 times daily

children 12 years or younger:

• ask a doctor
  

STORAGE AND HANDLING

Other information

• some individuals may not experience pain relief until several hours after applying the patch
• avoid storing product in direct sunlight
• protect product from excessive moisture
• store at 20o-25oC (68o-77oF)
  

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

UNITED EXCHANGE CORP.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY CARE THERA FLEX PAIN  
capsaicin, camphor, menthol, methyl salicylate, peppermint oil, zinc oxide patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65923-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0056 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.48 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.95 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	3.95 g
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B)	PEPPERMINT OIL	1.95 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.77 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CALCIUM CARBONATE (UNII: H0G9379FGK)
NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65923-100-10	1 in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/30/2012

Labeler - UNITED EXCHANGE CORP (840130579)