Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
Methyl Salicylate 7%, Menthol 13%, Camphor 12%
Indo Abadi Sari Makmur, PT
TOPICAL
OTC DRUG
Methyl Salicylate External Analgesic Menthol External Analgesic Camphor External Analgesic Relieves muscle pains, lumbago, insect bites, itching
OTC monograph not final
BALM STICK- CAMPHOR, MENTHOL, METHYL SALICYLATE STICK INDO ABADI SARI MAKMUR, PT _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- INDO ABADI SARI MAKMUR, PT 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. WARNINGS Keep out of reach of children. WARNINGS 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 BALM STICK camphor, menthol, methyl salicylate stick PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:70815-001 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 7 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 13 g in 100 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 12 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH EUCALYPTUS OIL (UNII: 2R04ONI662) CAPSICUM (UNII: 00UK7646FG) PEPPERMINT OIL (UNII: AV092KU4JH) BORNEOL (UNII: M89NIB437X) Les hele dokumentet