FDA Label for Kalaya Extra Strength Pain Relief Gel With Arnica
View Indications, Usage & Precautions
Kalaya Extra Strength Pain Relief Gel With Arnica Product Label
The following document was submitted to the FDA by the labeler of this product Avaria Health & Beauty 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.
Drug Facts
Active Ingredients
Camphor 4%
Menthol 4%
Methyl salicylate 11%
Purpose
Topical Analgesic
Uses
Penetrating pain relief for the temporary relief of minor aches and pains of muscle and joint pain associated with arthritis, backache, strains, sprains and bruises.
Warnings
For external use only
Do not use
- on wounds or damaged skin
- with a heating pad
- on children under 12 years of age with arthritis-like conditions
- avoid contact with eyes or mucous membranes
- do not bandage tightly
- condition worsen or symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- excessive skin irritation occurs
When using this product
Stop use and ask a doctor
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Cntrol Center right away.
Directions
Adults and children 12 years and over. Use no more than 3-4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.
Other Information
• Store at 59°F - 77°F
• If seal is broken, do not use
Inactive Ingredients
Alcohol Denat., Aminomethyl propanol, Arnica Montana Flower Extract, Carbopol Ultrez 10, Cetearyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Glycerin, Polysorbate 80, Water
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Product Label
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