Label: REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM- glycerin, allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 81459-302-01 - 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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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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,Eucalyptus Globulus Leaf Oil, Dipropylene Glycol,Caprylic/Capric
Triglyceride,Polyglyceryl-3 Methylglucose Distearate,Cetearyl
Alcohol,Limnanthes Alba (Meadowfoam) Seed Oil,Hydrogenated
Poly(C6-14 Olefin),Hydrogenated Polydecene,Glyceryl Stearate,
Dendropanax Morbiferus Extract,Cetearyl Olivate,Sorbitan Olivate,
Behenyl Alcohol,Butylene Glycol,Oryza Sativa (Rice) Extract,Pinus
Densiflora Leaf Extract,Cyanocobalamin,Copper Tripeptide-1,
Ceramide NP,Hydrogenated Lecithin,Hydrolyzed Vegetable Protein,
Maltodextrin,Centella Asiatica Extract,Sodium Citrate,Polygonum
Cuspidatum Root Extract,Scutellaria Baicalensis Root Extract,
Propolis Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Camellia
Sinensis Leaf Extract,Rosmarinus Officinalis(Rosemary) Leaf Extract,
Chamomilla Recutita (Matricaria) Flower Extract,Simethicone,
Butyrospermum Parkii (Shea) Butter,Sodium Acrylate/Sodium
Acryloyldimethyl Taurate Copolymer,Caprylyl Glycol,Carbomer,
Polyisobutene,Tromethamine,Xanthan Gum,Dextrin,Salvia Officinalis
(Sage) Oil,Sorbitan Oleate,Caprylyl/Capryl Glucoside,Juniperus
Mexicana Oil,Hydrolyzed Gardenia Florida Extract ,Gardenia Florida
Fruit Extract,Dipotassium Glycyrrhizate,Citric Acid,1,2-Hexanediol,
Ethylhexylglycerin,Hydroxyacetophenone,Disodium EDTA - Package Label
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INGREDIENTS AND APPEARANCE
REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM
glycerin, allantoin creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81459-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN 0.001 mg in 100 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 mg in 100 mL Inactive Ingredients Ingredient Name Strength DOCOSANOL (UNII: 9G1OE216XY) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) RICE GERM (UNII: 7N2B70SFEZ) PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CHAMOMILE (UNII: FGL3685T2X) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) XANTHAN GUM (UNII: TTV12P4NEE) SAGE OIL (UNII: U27K0H1H2O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987) HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529) DIMETHICONE (UNII: 92RU3N3Y1O) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) ICODEXTRIN (UNII: 2NX48Z0A9G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN OLIVATE (UNII: MDL271E3GR) CERAMIDE NP (UNII: 4370DF050B) POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) CETEARYL OLIVATE (UNII: 58B69Q84JO) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ROSEMARY (UNII: IJ67X351P9) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TROMETHAMINE (UNII: 023C2WHX2V) EUCALYPTUS OIL (UNII: 2R04ONI662) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CYANOCOBALAMIN (UNII: P6YC3EG204) PREZATIDE COPPER (UNII: 6BJQ43T1I9) MALTODEXTRIN (UNII: 7CVR7L4A2D) CENTELLA ASIATICA (UNII: 7M867G6T1U) SODIUM CITRATE (UNII: 1Q73Q2JULR) POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) PROPOLIS WAX (UNII: 6Y8XYV2NOF) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SHEA BUTTER (UNII: K49155WL9Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81459-302-01 80 mL in 1 TUBE; 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(81459-302)
