Label: REPUERA DERMATOZYME 5% HYDRO ESSENTIAL AMPULE- allantoin, glycerin liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 81459-303-01 - Packager: ALLUV
- 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 January 28, 2021
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- Active Ingridients
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
- Other Information
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Inactive Ingredients
Water,Diphenyl Dimethicone, Dendropanax Morbiferus Extract,Ceramide NP,Cyanocobalamin,Sodium Hyaluronate,Copper Tripeptide-1, Tripeptide-1,Palmitoyl Pentapeptide-4, Oligopeptide-1, Dipeptide-2,Dipropylene Glycol,Oryza Sativa (Rice) Extract,Pinus Densiflora Leaf Extract,Rosmarinus Officinalis (Rosemary)Leaf Extract,Chamomilla Recutita (Matricaria) Flower Extract,Maltodextrin, Salvia Officinalis(Sage) Oil, Eucalyptus Globulus Leaf Oil, Juniperus Mexicana Oil,Butylene Glycol,Hydrolyzed Vegetable Protein,Hydrolyzed Gardenia Florida Extract,Gardenia Florida Fruit Extract,Dipotassium Glycyrrhizate, Centella Asiatica Extract,Hydrogenated Lecithin,Sodium Citrate,Polygonum Cuspidatum Root Extract,Scutellaria Baicalensis Root Extract,Propolis Extract, Phytosteryl/Octyldodecyl Lauroyl Glutamate,Glycyrrhiza Glabra(Licorice) Root Extract,Leontopodium Alpinum Callus Culture Extract,Camellia Sinensis Leaf Extract,Caprylic/Capric Triglyceride, Citric Acid,Caprylyl Glycol,1,2-Hexanediol, Calcium Chloride,Gellan Gum, Ethylhexylglycerin,Hydroxyacetophenone, Xanthan Gum,Dextrin
- Package Label
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INGREDIENTS AND APPEARANCE
REPUERA DERMATOZYME 5% HYDRO ESSENTIAL AMPULE
allantoin, glycerin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81459-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 15 mg in 100 mL ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.01 mg in 100 mL Inactive Ingredients Ingredient Name Strength CYANOCOBALAMIN (UNII: P6YC3EG204) HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) LINALOOL, (+/-)- (UNII: D81QY6I88E) DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O) CHAMOMILE (UNII: FGL3685T2X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) CENTELLA ASIATICA (UNII: 7M867G6T1U) SODIUM CITRATE (UNII: 1Q73Q2JULR) WATER (UNII: 059QF0KO0R) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PREZATIDE COPPER (UNII: 6BJQ43T1I9) VALYLTRYPTOPHAN (UNII: 3G64B4AFQN) DIPROPYLENE GLYCOL (UNII: E107L85C40) PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY) EUCALYPTUS OIL (UNII: 2R04ONI662) MALTODEXTRIN (UNII: 7CVR7L4A2D) SAGE OIL (UNII: U27K0H1H2O) PROPOLIS WAX (UNII: 6Y8XYV2NOF) PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) XANTHAN GUM (UNII: TTV12P4NEE) GERANIOL (UNII: L837108USY) LIMONENE, (+)- (UNII: GFD7C86Q1W) CERAMIDE NP (UNII: 4370DF050B) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PREZATIDE (UNII: 39TG2H631E) PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG) RICE GERM (UNII: 7N2B70SFEZ) ROSEMARY (UNII: IJ67X351P9) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81459-303-01 50 mL in 1 AMPULE; Type 0: Not a Combination Product 01/28/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/28/2021 Labeler - ALLUV (695097760) Registrant - ALLUV (695097760) Establishment Name Address ID/FEI Business Operations ALLUV 695097760 manufacture(81459-303)
