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

repuera DermAtozyme 5% Ultra Moisture Cream by

Drug Labeling and Warnings

repuera DermAtozyme 5% Ultra Moisture Cream by is a Otc medication manufactured, distributed, or labeled by ALLUV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM 
glycerin, allantoin cream

Product 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)