Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Uncle Bill Trading USA Inc.
TOPICAL
OTC DRUG
external analgesic external analgesic external analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains ■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ Pain persists for more than 10 days conditions ■ Redness is present ■ Conditions affect children under 12 years of age
OTC monograph not final
ZHENWEILONG HUOLUO YOU EXTERNAL ANALGESIC- CAMPHOR MENTHOL METHYL SALICYLATE OIL UNCLE BILL TRADING USA 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_ Camphor 10% Menthol 15% Methyl Salicylate 30% _PURPOSE_ external analgesic external analgesic external 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 getting into the eyes or on mucous membranes ■ Discontinue use if excessive irritation of the skin develops WHEN USING THIS PRODUCT ■ Do not apply to wound or damaged skin. ■ Do not bandage tightly STOP USE AND ASK A DOCTOR IF ■ Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days ■ Pain persists for more than 10 days conditions ■ Redness is present ■ Conditions affect 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 12 years of age and older apply to affected area not more than 3 to 4 time daily. ■ Children under 12 years of age, consult a doctor before using ■ Do not use otherwise than as directed _INACTIVE INGREDIENTS_ Dragon's blood (resin), eucalyptus oil, mineral oil, peppermint oil PACKAGE LABEL ZHENWEILONG HUOLUO YOU EXTERNAL ANALGESIC camphor menthol methyl salicylate oil Uncle Bill Trading USA Inc. PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:49 9 52-0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) - UNII:N20 HL7Q9 41) CAMPHOR (NATURAL) 10 g in 10 0 m Read the complete document