Country: United States
Language: English
Source: NLM (National Library of Medicine)
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)
MADISON ONE ACME INC
TRANSDERMAL
OTC DRUG
Purpose External analgesic External analgesic Uses For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ simple backache ■ bruises ■ sprains Do not use ■ on wounds ■ on damaged or irritated skin ■ if excessive irritation develops ■ otherwise than as directed, to do so may be dangerous 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 ■ when using for pain of arthritis if: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age
OTC monograph not final
WU YANG BRAND PAIN RELIEVING MEDICATED- MENTHOL AND CAMPHOR PLASTER 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 INGREDIENTS_ Menthol 5% Camphor 3% _PURPOSE_ External analgesic External analgesic _USES_ For the temporary relief of minor aches and pains of muscles and joints due to: ■ arthritis ■ strains ■ simple backache ■ bruises ■ sprains _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE ■ on wounds ■ on damaged or irritated skin ■ if excessive irritation develops ■ otherwise than as directed, to do so may be dangerous WHEN USING THIS PRODUCT ■ avoid contact with the eyes or mucous membranes ■ do not bandage tightly 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 ■ when using for pain of arthritis if: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age 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 2 years of age and older: Cut to desired size, remove clear backing, and apply to affected area not more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a doctor. _OTHER INFORMATION_ ■ store at 15º to 30º C (59º to 86º F) in a dry place away from sunlight _INACTIVE INGREDIENTS_ angelica dahurica root, butylated hydroxytoluene, cinnamon oil, dipsacus asper root, dragon's blood, drynaria fortunei root, gardenia jasminoides fruit, ginger, lanolin, light mineral oil, lonicera japonica flower, methyl salicylate, myrrh, natural latex rubber, nepeta tenuifolia flowering top, petrolatum, polyisobutylene, rheum officinale root, rosin, safflower, saposhnikovia divar Read the complete document