REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM- glycerin, allantoin cream 
ALLUV

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.

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81459-302 re'puera DermAtozyme 5% Ultra Moisture Cream

Active Ingridients

Glycerin (10%)

Allantoin (0.001%)

Purpose

Skin Protectant

Uses

pH 5.8 Less-Acid cream. Maintains healthy and smooth skin by providing sufficient nourishment from the inside of the skin.

Warnings

For external use only

keep away from heat.

When using this product

keep out of eyes.

Stop use and ask a doctor if

irritation or rash occurs.

Keep out of reach of children.

Keep out of reach of children.

Directions

Apply the cream to affected area and
massage gently into the skin.

Other Information

STORE AT ROOM TEMPERATURE

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

81459-302-01

REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM 
glycerin, allantoin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81459-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.001 mg  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81459-302-0180 mL in 1 TUBE; Type 0: Not a Combination Product01/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/28/2021
Labeler - ALLUV (695097760)
Registrant - ALLUV (695097760)
Establishment
NameAddressID/FEIBusiness Operations
ALLUV695097760manufacture(81459-302)

Revised: 1/2021
Document Id: b9f185bf-25e6-eaea-e053-2995a90a22b5
Set id: b9f185bf-25e5-eaea-e053-2995a90a22b5
Version: 1
Effective Time: 20210128
 
ALLUV