CORALITE MUSCLE JOINT- camphor menthol menthyl salicylate patch United Exchange Corp. 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. ------Active ingredients Purpose Camphor 1.2%...... Topical analgesic Menthol 5.7%...... Topical analgesic Methyl Salicylate 6.3%...... Topical analgesic Uses For temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains
Warnings For external use only Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use. Do not use on wounds or damaged skin with a heating pad if you are allergic to any ingredients of this product
When using this product do not use other than directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly
Stop use and ask a doctor if: rash, itching, or excessive skin irritation develops conditions worsen symptoms persist for more than 7 days symptoms clear up and occur again within a few days
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 Poision Control Center right away. Directions Adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily remove patch from skin after at most 8 hours of application Children under 12 years of age: consult with a doctor Other information avoid storing product in direct sunlight protect from excessive moisture
Inactive ingredients butylated hydroxytoluene, glyceryl rosinate, natural rubber, polybutene, polyisobutylene, precipitated calcium carbonate, quinton, sorbitan stearate, tocopherol acetate, YS resin, zinc oxide DISTRIBUTED BY: UNITED EXCHAGE CORP. 17211 VALLY VIEW AVE. CERRITOS, CA 90703
CORALITE MUSCLE JOINT camphor menthol menthyl salicylate patch
Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 59 23-155 Route of Administration TOPICAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHO R (NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) - CAMPHOR .0 12 mg in 10 0 mg UNII:N20 HL7Q9 41) (NATURAL) .0 57 mg MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL in 10 0 mg METHYL .0 6 3 mg METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLATE in 10 0 mg
Inactive Ingredients Ingredient Name Strength BUTYLATED HYDRO XYTO LUENE (UNII: 1P9 D0 Z171K) GLYCERYL RO SINATE (UNII: SD112V49 2J) NATURAL LATEX RUBBER (UNII: 2LQ0 UUW8 IN) PO LYBUTENE (14 0 0 MW) (UNII: 1NA5AO9 GH7) PO LYISO BUTYLENE (10 0 0 MW) (UNII: 5XB3A6 3Y52) CALCIUM CARBO NATE (UNII: H0 G9 379 FGK) ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 ) ZINC O XIDE (UNII: SOI2LOH54Z)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:6 59 23-155-0 2 2 in 1 POUCH 0 7/13/20 17 1 1 mg in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct
Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph no t final part348 12/11/20 13
Labeler - United Exchange Corp. (840130579)
Revised: 7/2017 United Exchange Corp.