Active Ingredients
Methyl Salicylate 7%
Menthol 13%
Camphor 12%
Balm Stick
FDA Label NDC 70815-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Indo Abadi Sari Makmur, Pt for the product Balm Stick (NDC 70815-001). 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, directions, warnings, other information, inactive ingredients, drug facts, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Methyl Salicylate External Analgesic
Menthol External Analgesic
Camphor External Analgesic
Uses
Relieves muscle pains, lumbago, insect bites, itching
Directions
Apply to the affected area as needed.
Warnings
External Use Only. Do not use for children below 2 years of age. Avoid direct application into the nostrils.
Keep out of reach of children.
Stop use and ask doctor if
Condition worsens
Symptoms persist for more than 7 days
Symptoms clear up and occur again within a few days
Excessive irritation of the skin develops
Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs
When using for pain of arthritis: pain persits for more than 10 days, redness is present, in conditions affecting children 12 years of age.
Other Information
Keep container tightly closed. Store at 16 to 30 degrees centigrade (69 to 86 Farenheit).
Inactive Ingredients
Eucalyptus Oil, Capsicum, Peppermint Oil, Borneol
Drug Facts
Image (Carton)
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