Active Ingredient
Menthol 10%
Methyl Salicylate 15%
Analgesic Balm Cream
FDA Label NDC 57896-116
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceuticals, Corp for the product Analgesic Balm (NDC 57896-116). 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, keep out of the reach of children, directions, other information, 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
- On a child under 12 years of age with arthritis-like conditions
- With a heating pad
- Avoid contact with eyes or mucous membranes
- Do not bandage tightly
Ask a doctor before use if you have redness over the affected area.
When using this product
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
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Directions
- Use only as directed
- 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 1-800-540-3765
Inactive Ingredients
Carbomer 940, Cetyl alcohol, Glycerol, Glyceryl monostearate, Methylparaben, Polysorbate 80, Propylparaben, Purified Water, Stearic acid, Trolamine
Distributed By
Distributed By
GeriCare Pharmaceuticals
1650 63rd Street
Brooklyn, NY 11204
Made in China
* Please review the disclaimer below.
