FDA Label for Family Care Thera Flex Pain
View Indications, Usage & Precautions
Family Care Thera Flex Pain Product Label
The following document was submitted to the FDA by the labeler of this product United Exchange Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - 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
Otc - 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
Otc - 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
Otc - 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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding, ask a health professional before use.
Otc - 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
Package Label.Principal Display Panel
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