Label: BIOMEGA- capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 64058-355-18 - 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 21, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
- This is not a face cream. Do not apply to the face.
- Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
- Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
- Do not bandage tightly.
- Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
- Do not use with heating pad, hot water bottle or other source of heat Doing so can increase risk of serious burns.
When using this product
- Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.
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Directions
- Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
- Before using on children under 18 years of age consult a physician.
- Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
- Gently massage into the skin until fully absorbed.
- Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
- A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort remove excess product with a soft cloth and cooking oil.
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Inactive ingredients
Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita Leaf Extract, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
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INGREDIENTS AND APPEARANCE
BIOMEGA
capsaicin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-355 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin 2.5 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489) ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) LAURYL LAURATE (UNII: GPW77G0937) STARCH, CORN (UNII: O8232NY3SJ) HYDRATED SILICA (UNII: Y6O7T4G8P9) GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) ALFALFA (UNII: DJO934BRBD) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W) ROSEMARY (UNII: IJ67X351P9) MENTHA PIPERITA LEAF (UNII: A389O33LX6) ASIAN GINSENG (UNII: CUQ3A77YXI) GINKGO (UNII: 19FUJ2C58T) FLAX SEED (UNII: 4110YT348C) CELOSIA ARGENTEA SEED (UNII: O1H314U8M2) ACAI (UNII: 46AM2VJ0AW) EDETATE DISODIUM (UNII: 7FLD91C86K) EMU OIL (UNII: 344821WD61) POLYSORBATE 20 (UNII: 7T1F30V5YH) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) Ethylhexylglycerin (UNII: 147D247K3P) Hexylene Glycol (UNII: KEH0A3F75J) CETEARYL ISONONANOATE (UNII: P5O01U99NI) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARETH-12 (UNII: 7V4MR24V5P) CETYL PALMITATE (UNII: 5ZA2S6B08X) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64058-355-18 238 g in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 08/31/2016 Labeler - Concept Laboratories, Inc. (962282612) Establishment Name Address ID/FEI Business Operations Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-355)
