Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Pharmadel LLC
TOPICAL
OTC DRUG
For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains
OTC monograph not final
UBREDOL- METHYL SALICYLATE OINTMENT PHARMADEL LLC _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._ ---------- UBREDOL METHYL SALICYLATE 10% (WP) _DRUG FACTS_ _ACTIVE INGREDIENT & PURPOSE_ _ACTIVE INGREDIENT_ _PURPOSE_ Methyl salicylate 10% .................. Topical analgesic _USES_ For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains _WARNINGS_ FOR EXTERNAL USE ONLY. AVOID CONTACT WITH THE EYES. _DO NOT_ apply on wounds or irritated skin bandage tightly STOP USE AND ASK DOCTOR IMMEDIATELY IF condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed get medical help, or contact a Poison Control Center immediately. _DIRECTIONS_ ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: apply to affected area not more than 3 to 4 times daily CHILDREN UNDER 12 YEARS OF AGE: do not use, consult a doctor _OTHER INFORMATION_ store between 59°- 86°F (15 - 30°C) do not use if clear seal over jar is broken, torn or missing _INACTIVE INGREDIENTS_ camphor, D&C yellow #11, eucalyptus oil, lanolin oil, levomenthol, mineral oil, petrolatum, propylparaben, tea tree oil DISTRIBUTED BY: PHARMADEL LLC New Castle, DE 19720 +1-866-359-3478 _PRINCIPAL DISPLAY PANEL_ Pharmadel LLC UBREDOL methyl salicylate ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:55758-377 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 100 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CAMPHOR, (-)- (UNII: 213N3S8275) LEVOMENTHOL (UNII: BZ1R15MTK7) D&C YELLOW NO. 11 (UNII: 44F3HYL9 Les hele dokumentet