Label: MY OMEGA 3 RUB (menthol, unspecified form and camphor- synthetic cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64058-345-68 - Packager: Concept Laboratories, Inc.
- 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 September 13, 2016
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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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 liberally 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, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
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INGREDIENTS AND APPEARANCE
MY OMEGA 3 RUB
menthol, unspecified form and camphor (synthetic) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-345 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) HYDRATED SILICA (UNII: Y6O7T4G8P9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-345-68 234 g in 1 BOTTLE; Type 0: Not a Combination Product 06/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 06/27/2016 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-345)