NDC | 64058-341-64 |
Set ID | 4d044ecc-2e1f-4cc1-8202-8c65b563e7c5 |
Category | HUMAN OTC DRUG LABEL |
Packager | Concept Laboratories, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only.
- do not apply to wounds or damaged skin
- do not bandage tightly
- do not use with heating pad, pack, wrap, hot water bottle or any heating element
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Directions
- Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
- Children under 12 years of age consult a physician
- Apply a thin layer to affected area not more than 3 to 4 times daily
- Gently massage into the skin until fully absorbed
- Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
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Inactive ingredients
Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol (Phenagon PDI), DMDM Hydantoin, Iodopropynyl Butylcarbamate.
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
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INGREDIENTS AND APPEARANCE
TRIPLE POWER PAIN RELIEF
menthol, unspecified form and camphor (synthetic) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-341 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 0.12 g in 1 g CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 0.06 g in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEPPERMINT OIL (UNII: AV092KU4JH) ALCOHOL (UNII: 3K9958V90M) STARCH, CORN (UNII: O8232NY3SJ) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) LINSEED OIL (UNII: 84XB4DV00W) ROSEMARY OIL (UNII: 8LGU7VM393) ACAI OIL (UNII: Z0W6766A2W) PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) LAURYL LAURATE (UNII: GPW77G0937) DMDM HYDANTOIN (UNII: BYR0546TOW) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-341-64 106 g in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/25/2015 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-341)