Otc - Active Ingredient
Methyl Salicylate 18%
Menthol 10%
Heating Pain Relief Cream
FDA Label NDC 49283-579
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chemco Corporation for the product Heating Pain Relief (NDC 49283-579). 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, otc - purpose, use, warnings, otc - when using, stop use and ask a doctor if, if pregnant or breast-feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic.
Use
Aid for temporary local relief of minor pain in muscles or joints.
Warnings
For external use only. · Ask a doctor before use if you have redness over affected area
Otc - When Using
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, broken or irritated skin
If you experience an allergic reaction, discontinue use and consult a doctor.
Do not expose the area treated with product to heat or direct sunlight.
Stop Use And Ask A Doctor If
Condition worsens
Redness is present
Irritation develops
Symptoms persist for more than 7 days or clear up occur again within a few days
You experience signs injury, such as pain, swelling or blistering where the product was applied.
If Pregnant Or Breast-Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and Children over 12 years
Apply a small amount on the affected area.
Massage in circular motion, let set for a few seconds..
Repeat as necessary, but no more than 3 to 4 times daily.
Wash hands with soap and water after use.
Children under 12 years of age consult a doctor.
Other Information
Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).
Inactive Ingredient
Water (Aqua), Paraffinum Liquidum, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Glycereth-26, Dimethicone, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Caprylyl Glycol, Hexylene Glycol, Stearyl Alcohol, Triethanolamine, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cannabis Sativa (Hemp) Seed Oil, Phenoxyethanol, FD&C Yellow No.6 (CI 15985).
Generic Label - Ultra Strenght Pain Relief Cream
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