Country: United States
Language: English
Source: NLM (National Library of Medicine)
Menthol 3%, Methyl Salicylate 10%
Labocont Industrial
TOPICAL
OTC DRUG
Counterirritant Counterirritant 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 redness is present excessive irritation of the skin develops
OTC monograph not final
FRICCILICONT- MENTHOL, METHYL SALICYLATE CREAM LABOCONT INDUSTRIAL _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._ ---------- FRICCILICONT OINTMENT ACTIVE INGREDIENTS Menthol 3% Methyl Salicylate 10% PURPOS E Counterirritant Counterirritant US ES 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. WHEN USING THIS PRODUCT do not apply to wounds or damaged skin do not bandage tightly STOP USE AND ASK A DOCTOR condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days redness is present excessive irritation of the skin develops IF PREGNANT OR BREAST-FEEDING ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a physician. INACTIVE INGREDIENTS stearic acid, turpentine, water SHAKE DO NOT DRINK Ointment Friccilicont EXTERNAL ANALGESIC EFFECTIVE AND REINFORCED LABOCONT INDUSTRIAL Sto. Dgo., Rep. Dom. LABORATORIOS, C. x A. Made In Dominican Republic Net Wt 10 oz (284 g) MADE IN DOMINICAN REPUBLIC MANUFACTURED FOR LABOCONT INDUSTRIAL, Km 19, Autopista las Americas, La Caleta. Sto. Dgo DOMINICAN REPUBLIC TO REPORT A SERIOUS ADVERSE EVENT CONTACT 8109-756- 7371 FRICCILICONT menthol, methyl salicylate cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:530 38 -0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 3 g in 10 0 g METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC Read the complete document