国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Eagle Indo Pharma
TOPICAL
OTC DRUG
Topical Analgesic Topical Analgesic temporarily relieves the minor aches and pains of muscle and joints associated with : ■simple backache ■strains ■bruises ■sprains ■ on wounds or damaged skin ■ with a heating pad you have redness over affected area ■condition worsens or symptoms persist for more than 7 days ■symptoms clear up and occur again within a few days ■excessive skin irritation occurs
OTC monograph not final
EAGLE MEDICATED- MENTHOL METHYL SALICYLATE OIL EAGLE INDO PHARMA _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._ ---------- EAGLE MENTHOL MTHYLSLCYLTE OIL _ACTIVE INGREDIENTS_ Menthol 14.5% Methyl Salicylate 30% _PURPOSE_ Topical Analgesic Topical Analgesic _USES_ temporarily relieves the minor aches and pains of muscle and joints associated with : ■simple backache ■strains ■bruises ■sprains _WARNING_ FOR EXTERNAL USE ONLY DO NOT USE ■ on wounds or damaged skin ■ with a heating pad ASK A DOCTOR BEFORE USE IF you have redness over affected area WHEN USING THIS PRODUCT ■avoid contact with eyes or mucous membranes ■do not bandage tightly STOP USE AND ASK A DOCTOR IF ■condition worsens or symptoms persist for more than 7 days ■symptoms clear up and occur again within a few days ■excessive skin irritation occurs _KEEP OUT OF REACH OF CHILDREN_ _KEEP OUT OF REACH OF CHILDREN_ To avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ ■ Use only as directed ■adults and children 2 years and over: apply to affected area not more than 3 to 4 time daily ■children under 2 years of age: ask a doctor _INACTIVE INGREDIENTS_ D&C Green No. 6, D&C Yellow No. 11, ethyl alcohol, mineral oil, rose oil _QUESTION?_ 1-800-777-6717 or 1-800-645-0769 PACKAGE LABEL EAGLE MEDICATED menthol methyl salicylate oil PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:60954-008 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 14.5 g in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ 4LPZ ) METHYL SALICYLATE 30 g in 100 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH D&C YELLOW NO. 11 (UNII: 44F3HYL954) D&C GREEN NO. 6 (UNII: 4QP5U84YF 完全なドキュメントを読む