Label: PAIN RELIEFPATCHES PATCHES- dl-camphor l-menthol methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 53043-001-01 - Packager: Shanghai Aquagel Bio-Plymer Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 15, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients
For External Use Only
DL-Camphor 1.2%.......................................................................................................................................Topical analgesic
L-Menthol 4.0%..........................................................................................................................................Topical analgesic
Methyl Salicylate 6.3%................................................................................................................................Topical analgesic
- PURPOSE
- WARNINGS
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INDICATIONS & USAGE
Do not use
other than as directed on wounds, damaged or irritated skin in combination with other external analgesic
products, ointments, creams or with a heating pad. in contact with eyes or mucous membranes. if you are
allergic to any ingredient in this product. if you have a history of allergic reactions to this or similar products
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults and children 12 years of age and over: Clean and dry the affected area. Remove patch from film backing. Adhere
to area for no more than 8 hours at a time, not more than 3 times per day, and for no more than 7 days continuously.
Children under 12 years of age: Consult a doctor before use.
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PAIN RELIEFPATCHES PATCHES
dl-camphor l-menthol methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53043-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.2 mL in 100 mL LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 4 mL in 100 mL METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 6.3 mL in 100 mL Inactive Ingredients Ingredient Name Strength AMMONIUM STEARATE (UNII: 37899330TZ) CALCIUM CARBONATE (UNII: H0G9379FGK) GLYCERYL ABIETATE (UNII: 2F22LY70Q1) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN) POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) PROPYLENE CARBONATE (UNII: 8D08K3S51E) STYRENE (UNII: 44LJ2U959V) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53043-001-01 20 in 1 CARTON 1 24 mL in 1 PATCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/01/2012 Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544) Establishment Name Address ID/FEI Business Operations Shanghai Aquagel Bio-Plymer Co., Ltd 421199544 manufacture(53043-001)