Drug Facts
Menthol-6%, Methyl Salicylate-14%
Purpose: External analgesic
Analgesic Balm
FDA Label NDC 54162-555
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Analgesic Balm (NDC 54162-555). 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 drug facts, uses, directions, dosage & administration, warnings, inactive ingredient, storage, 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
Uses
For the temporary relief of
minor aches and pain of muscles
and joints.
Directions
Adults and children
2 years of age and older: Apply
generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.
Dosage & Administration
Apply generously to affected area not
more than 3 to 4 times daily.
Children under 2 years of age:
Consult a doctor.
Warnings
Avoid contact with eyes or
mucous membranes. Discontinue
use if excessive irritation of the
skin develops.
• Do not: bandage tightly; apply
to wounds, damaged skin, or
use with a heating pad.
• If condition worsens, or if
symptoms persist more than
7 days or clear-up and reoccur
again within a few days,
discontinue use of this product
and consult a doctor. If
swallowed, get medical help
or contact a Poison Control
Center immediately.
Inactive Ingredient
Acylates Copolymer, DMDM Hydantoin,
Lanolin, Paraffin Wax,
Peg-40 Hydrogenated Castor Oil,
Petrolatum, Phenoxyethanol, Water.
Storage
At room temperature
20°-25° C (68°-77° F). Close cap
tightly after use.
Otc - Keep Out Of Reach Of Children
Children under 2 years of age:
Consult a doctor.
* Please review the disclaimer below.
