FDA Label for Careone Extra Strength Cold And Hot
View Indications, Usage & Precautions
Careone Extra Strength Cold And Hot Product Label
The following document was submitted to the FDA by the labeler of this product American Sales Company. 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 ingredient Purpose
Menthol 5%.................................. Topical analgesic
Otc - Purpose
Uses
Temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- bruises
- cramps
Warnings
Warnings
For external use only
Otc - When Using
When using this product
- use only as directed
- do not bandage tightly or use with a 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
- condition worsens
- redness is present
- irritation develops
- symptoms persist for more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poision Control Center right away
Indications & Usage
Directions
adults and children over 12 years:
- remove backing from patch by grasping both ends firmly and gently pulling until backing seperates in middle
- carefully remove backing from patch
- apply one patch to affected area
- wear one patch up to 8 hours
- repeat as necessary, but no more than 4 times daily
children 12 years or younger: consult a doctor
Storage And Handling
Other information
- store at room temperature, not to exceed 86°F (30°C)
Inactive Ingredient
Inactive ingredients
alove vera, aluminum hydroxide, BHT, castor oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrolidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-waven fabric
Dosage & Administration
Distributed by:
Foodhold U.S.A., LLC
Landover, MD 20785
Made in Korea
Package Label.Principal Display Panel
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