FDA Label for Care One Cool Heat Pain Relieving
View Indications, Usage & Precautions
Care One Cool Heat Pain Relieving 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 ingredients Purpose
Menthol 10%............................................................................................Topical Analgesic
Methyl Salicylate 30%...............................................................................Topical Analgesic
Otc - Purpose
Uses
temporarily relieves minor pain associated with
- Arthritis
- Simple backache
- Muscle strains
- Sprains
- Bruises
- Cramps
Warnings
Warning
For external use only
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Otc - When Using
When using this product
- Use only as directed
- Do not bandage tightly or sue with a heating pad
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds, damaged, broken or irritated 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
- irritation develops
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. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
Indications & Usage
Directions Adults and children over 12 years
- apply generously to affected area
- massage into painful area until thoroughly absorbed into skin
- repeat as necessary but no more than 4 times daily
- close cap tightly after use
- keep carton as it contains important information Children 12 years or younger: Ask a doctor
Inactive Ingredient
Inactive ingredients
Carbomer, Cetyl Esters, Emulsifying Wax, Oleth-3 phosphate, Stearic Acid, Triethanolamine, Water
Dosage & Administration
DISTRIBUTED BY: AMERICAN SALES COMPANY
4201 WALDEN AVENUE, LANCASTER, NY 14086
www.care1.info
Made in Korea
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