Active Ingredient
Menthol 10%
Methyl Salicylate 15%
Pain Reliever Cream
FDA Label NDC 69396-151
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Trifecta Pharmaceuticals Usa, Llc. for the product Pain Reliever Cream (NDC 69396-151). 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 active ingredient, otc - purpose, indications & usage, warnings, stop use and ask a doctor, ask a doctor before use, when using this product, keep out of the 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
Indications & Usage
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains
Warnings
For external use only
Do not use:
- On wounds or damaged, broken, (open) or irritated skin
- With a heating pad
Stop Use And Ask A Doctor
- Conditions worsens or does not improve within 7 days
- Symptoms clear up and occur again within a few days
- Excessive skin irritation develops
A temporary burning sensation may occur upon application, but generally disappears in a few days
Ask A Doctor Before Use
If you are pregant or breast feeding.
When Using This Product
Avoid contact with eyes or mucous membrane.
Do not bandage tightly
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
- Adults and children 12 years of age or older. Apply to the affected area not more than 3 to 4 times daily.
- Unless treating hands, wash hands thoroughly with soap and water immediately after use.
Children under 12 years of age. consult a doctor
Other Information
- Store at controlled room temperature 20°-25°C (68°-77°F)
Questions ?Call 1-800-883-0085
Inactive Ingredients
Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine
Distributed By
Proudly Distributed By
Associated Wholesale Grocers, Inc.
Kansas City, Kansas
66106
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