FDA Label for Balm Stick

View Indications, Usage & Precautions

Balm Stick Product Label

The following document was submitted to the FDA by the labeler of this product Indo Abadi Sari Makmur, Pt. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Methyl Salicylate  7%

Menthol  13%

Camphor  12%


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




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