Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Menthol 1.25%
Anicare Pharmaceuticals Pvt. Ltd.
TOPICAL
OTC DRUG
Topical Analgesic Temporary relieves of minor aches and pains in muscles and joints associated with - arthritis - simple backache - strains - bruises - sports injuries - sprains - condition worsens - symptoms last more than 7 days or clean up and occur again within a few days - redness or irritation develops
OTC monograph final
UNIVERSAL ICE COLD ANALGESIC- MENTHOL GEL ANICARE PHARMACEUTICALS PVT. LTD. _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._ ---------- UNIVERSAL ICE COLD ANALGESIC GEL ACTIVE INGREDIENTS Menthol 1.25% PURPOS E Topical Analgesic US ES Temporary relieves of minor aches and pains in muscles and joints associated with arthritis simple backache strains bruises sports injuries sprains WARNINGS FOR EXTERNAL USE ONLY DO NOT USE with other topical pain relievers with heating pads or heating devices WHEN USING THIS PRODUCT do not use in or near the eyes do not apply to wounds or damaged skin do not bandage tightly STOP USE AND ASK DOCTOR IF condition worsens symptoms last more than 7 days or clean up and occur again within a few days redness or irritation develops IF PREGNANT OR BREAST-FEEDING, ask a health professional before use KEEP OUT OF THE REACH OF CHILDREN KEEP OUT OF THE REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately. DIRECTIONS clean affected area before applying products adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily. INACTIVE INGREDIENTS Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1 PRINCIPAL DISPLAY PANEL ICE COLD ANALGESIC GEL 8 FL.OZ (237 ml) UNIVERSAL ICE COLD ANALGESIC menthol gel PRODUCT INFORMATION Anicare Pharmaceuticals Pvt. Ltd. PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:470 46 -159 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 1.25 g in 10 0 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CAMPHO R ( SYNTHETIC) (UNII: 5TJD8 2A1ET) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) BUTYLATED HYDRO XYTO LUENE Aqra d-dokument sħiħ