Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
MADISON ONE ACME INC
TOPICAL
OTC DRUG
Purpose External analgesic External analgesic External analgesic Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains Do not use ■ on irritated or damaged skin ■ on wounds Stop use and ask a 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, vomiting, abdominal discomfort, diarrhea, or skin rash occurs ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) ■ when using for pain of arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age
OTC monograph not final
NECK AND LUMBAR PAIN RELIEVING BALM- CAMPHOR, MENTHOL, AND METHYL SALICYLATE OIL MADISON ONE ACME INC _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._ ---------- _DRUG FACTS_ _ACTIVE INGREDIENT_ Camphor 11% Menthol 16% Methyl salicylate 30% _PURPOSE_ External analgesic External analgesic External analgesic USES For the temporary relief of minor aches and pains of muscles and joints due to: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE ■ on irritated or damaged skin ■ on wounds ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE ■ any concerns about using this product WHEN USING THIS PRODUCT ■ do not use otherwise than as directed ■ avoid contact with the eyes or mucous membranes ■ do not bandage tightly ■ do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns) STOP USE AND ASK A 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, vomiting, abdominal discomfort, diarrhea, or skin rash occurs ■ you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) ■ when using for pain of arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age REPORT ANY UNEXPECTED SIDE EFFECTS from the use of this product to the FDA MedWatch Program KEEP OUT OF REACH OF CHILDREN to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ ■ adults and children 3 years of age and older: apply several drops and rub Into the affected area not more than 3 to 4 times daily ■ children under 3 Прочитать полный документ