Kalaya Extra Strength Foaming Pain Relief Liquid
FDA Label NDC 43493-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avaria Health & Beauty Corp for the product Kalaya Extra Strength Foaming Pain Relief (NDC 43493-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Camphor 3%
Menthol 8%
Methyl salicylate 15%
Purpose
Topical Analgesic
Uses
Provides penetrating pain relief for the temporary relief of minor aches and pains of muscles and joints
Warnings
For External Use Only. Flammable. Keep away from heat or flame.
Do not use:
• on wounds or damaged skin
• with a heating pad
• on a child under 12 years of age with arthritis-like conditions
When using this product avoid contact with eyes or mucous membranes, do not bandage tightly.
Stop use and ask a doctor if condition worsen or symptoms persist more than 7 days, symptoms clear up and occur again within a few days and/or excessive skin irritation occurs.
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults and children 12 years and over: Spray evenly onto affected areas no more than 3 to 4 times daily. Apply spray to affected areas and
allowed to dry or thoroughly massage until penetrated. Wash hands with soap and water after use.
Other Information
• Store at 59°F - 77°F
Inactive Ingredients
Alcohol Denat., Arnica Montana Flower Extract, Bis-Peg 12 Dimethicone, Bis-Peg 10 Dimethicone, Water
Questions Or Comments?
Call toll-free 1.888.829.7165
Product Label
Image Description (Pain Relief Foam)
* Please review the disclaimer below.
