Label: RETADOLOR (menthol and camphor- synthetic cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64058-241-13 - Packager: Concept Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 September 9, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only.
When using this product do not get into eyes
- avoid contact with other mucous membranes
Flammable: Keep from heat and flame.
Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days
- Directions
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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 Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octrenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 85g Bottle Label
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INGREDIENTS AND APPEARANCE
RETADOLOR PENETRATING COOL THERAPY
menthol and camphor (synthetic) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-241 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 10.2 g in 85 g Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 5.1 g in 85 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) DMDM HYDANTOIN (UNII: BYR0546TOW) PHENOXYETHANOL (UNII: HIE492ZZ3T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) LAURYL LAURATE (UNII: GPW77G0937) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) PEPPERMINT OIL (UNII: AV092KU4JH) ALCOHOL (UNII: 3K9958V90M) LINSEED OIL (UNII: 84XB4DV00W) ROSEMARY OIL (UNII: 8LGU7VM393) ACAI OIL (UNII: Z0W6766A2W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-241-13 85 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part348 07/27/2009 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE