FDA Label for Smart Sense Cold And Hot Extra Strength Medicated
View Indications, Usage & Precautions
Smart Sense Cold And Hot Extra Strength Medicated Product Label
The following document was submitted to the FDA by the labeler of this product Kmart Corporation. 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
- muscle sprains
- bruises
- cramps
Warnings
Warnings For external use only
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Indications & Usage
Directions
- adults and children 12 years of age and older
- peel off protective backing and apply sticky side to affected area
- carefully remove backing from patch
- should be used up to 8 hours
- should be used no more than 3 times a day
- children under 12 years of age consult a doctor
Storage And Handling
Other information
- store at room temperature, not to exceed 86°F (30°C)
Inactive Ingredient
Inactive ingredients aloe vera, aluminum hydroxide, BHT, caster oil, disodium edetate, gelatin, glycerin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methylparaben, polyethylene glycol monostearate, polysorbate 80, polyvinyl alcohol, polyvinyl pyrrlidone, purified water, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate. Release Liner: polypropylene, non-woven material: polyester non-woven fabric.
Dosage & Administration
Distributed By: Kmart Corporation
Hoffman Estates, IL 60179
Made in South Korea
Package Label.Principal Display Panel
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