Otc - Active Ingredient
Camphor 4%, Menthol 4%, Methyl Salicylate 11%
The following Structured Product Label (SPL) was submitted to the FDA by Avaria Health & Beauty Corp for the product Pain Relieving (NDC 43493-0002). 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 otc - active ingredient, indications & usage, warnings, dosage & administration, inactive ingredient, otc - purpose, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Camphor 4%, Menthol 4%, Methyl Salicylate 11%
Uses
Temporarily relieves minor muscle pain, joint pain. Temporarily relieves pain associated with: arthritis pain, backache, strains, sprains, and bruises.
Warnings
For external use only. Use only as directed. Do not use on wounds or damaged skin. When using this product avoid contact with eyes and mucous membranes, do not bandage tightly. Stop use and consult doctor if condition worsens or symptoms persist for more than 7 days or symptoms clear up and occur again within a few days.
Directions
Adults and children 12 years of age and older: use no more than 3 to 4 times daily. Apply cream to affected areas and thoroughly massage until penetrated. Wash hands with soap and water after use.
Inactive ingredients
Acrylates C10-30 alkyl acrylate crosspolymer, Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Ceteth-10 Phosphate, Cyclomethicone, Dicetyl Phosphate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isopropyl Palmitate, Methylsulfonylmethane (MSM), Phenoxyethanol, Triethanolamine.
Purpose
Topical Analgesic.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
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