Country: United States
Language: English
Source: NLM (National Library of Medicine)
Methyl Salicylate 2.0%, Menthol 1.0%, Camphor 0.5%
Finemost Corporation
TOPICAL
OTC DRUG
Methyl Salicylate Topical Analgesic Menthol Topical Analgesic Camphor Topical Analgesic For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises Discontinue if skin irritation develops.
OTC monograph not final
QUALI PATCH (COLD)- METHYL SALICYLATE, MENTHOL, CAMPHOR PATCH FINEMOST CORPORATION _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._ ---------- FINEMOST CORPORATION ACTIVE INGREDIENTS Methyl Salicylate 2.0% Menthol 1.0% Camphor 0.5% PURPOSE Methyl Salicylate Topical Analgesic Menthol Topical Analgesic Camphor Topical Analgesic USES For temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Sprains Strains Bruises WARNINGS 1. For external use only. Avoid applying around the eyes and mucous membranes, or open wounds. 2. Pregnant women, nursing mothers and any person with allergic reactions to drugs or cosmetics should consult physician before use. Children should use this product under supervision. STOP USE Discontinue if skin irritation develops. KEEP OUT OF REACH OF CHILDREN. Keep out of reach of children. DIRECTIONS 1. Clean and dry the affected areas before application. 2. Remove the protective film while applying the areas 1-2 times daily, cut into smaller size if desired. If necessary up to 3 sheets per day. 3. Use only as directed. Firmly affix with adhesive tapes or elastic bandages around joint areas to secure the patch if needed. STORAGE Store at room temperature away from direct sunlight. Properly sealed to remain fresh. INACTIVE INGREDIENTS Phellodendron Amurense Whole DISTRIBUTED BY Finemost Corp. DBA QualiHerb Cerritos, Ca 90703 Tel: (562)802-0035 Fax: (562)802-0625 Made in Taiwan DRUG FACTS QUALI PATCH (COLD) methyl salicylate, menthol, camphor patch PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:72026-881 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 2 g in 100 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) ME Read the complete document