Active Ingredients
Methyl Salicylate 12.5%
Capsaicin 0.025%
Atomic Balm Ointment
FDA Label NDC 82345-856
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Hygenic Company, Llc for the product Atomic Balm (NDC 82345-856). 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 ingredients, purpose, uses, warnings, consult a doctor, keep this and all drugs 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
Purpose
Counterirritant
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, bruises, simple backache, and arthritis.
Combined with stretching and calisthenics, Atomic Balm assists in the warm-up process, especially in cool, damp weather. Do not bandage tightly.
Warnings
For external use only.
Use only as directed. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Do not apply to wounds or damaged skin. Avoid contact with the eyes. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.
Consult A Doctor
before administering to children, including teenagers, with chicken pox or flu.
Keep This And All Drugs Out Of The Reach Of Children
to avoid accidental poisoning.
Directions
Gently massage into painful area. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor. To apply: spread 1/8 " layer of Atomic Balm over area. Do not bandage tightly.
Other Information
This product will cause mild skin irritation. Discontinue use is excessive irritation of skin develops. Use with caution on sensitive skin. Store in a cool, dry place with cap closed tightly.
Inactive Ingredients
Lanolin, Paraffin Wax, Petrolatum
Questions?
(800) 345-2231
Package Labeling:
Label7 (Label7)
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