NDC | 53043-001-01 |
Set ID | acba6dff-c4c4-46e7-9ae4-f06e8fe60afc |
Category | HUMAN OTC DRUG LABEL |
Packager | Shanghai Aquagel Bio-Plymer Co., Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
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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
-
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
-
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
-
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)