repuera DermAtozyme 5% Ultra Moisture Cream

Manufacturer
ALLUV
Effective date
2021-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:45

Key Label Information#

Active Ingredients And Purpose

Active Ingridients

Glycerin (10%) Allantoin (0.001%)

Purpose

Skin Protectant

Uses

Uses

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

Directions

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

Warnings

Warnings

For external use only keep away from heat.

Stop use and ask a doctor if

irritation or rash occurs.

Directions And Dosage

Uses

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

Directions

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

Other Label Information

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

Label Images#

Ultra Moisture Cream
Ultra Moisture Cream

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81459-302-012022-07-29C16284748780-1e4f33bdf-a971-d8a0-e053-dadaa90a6e4e81459-302 re'puera DermAtozyme 5% Ultra Moisture Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81459-302-01repuera DermAtozyme 5% Ultra Moisture Cream80 mL in 1 TUBECREAM801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81459-302REPUERA DERMATOZYME 5% ULTRA MOISTURE CREAM (GLYCERIN, ALLANTOIN) CREAM [ALLUV]1Legacy NDC, 1 package rows20210305_b9f185bf-25e5-eaea-e053-2995a90a22b5.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81459-30281459-302-01

Ingredients#

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
RICE GERM7N2B70SFEZIACT
PINUS DENSIFLORA LEAFQ1Q9P50WIYIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CHAMOMILEFGL3685T2XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
XANTHAN GUMTTV12P4NEEIACT
SAGE OILU27K0H1H2OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)P0TX083987IACT
HYDROGENATED POLYDECENE (1500 CST)4YI0729529IACT
DIMETHICONE92RU3N3Y1OIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
ICODEXTRIN2NX48Z0A9GIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALLANTOIN344S277G0ZACTIB
SORBITAN OLIVATEMDL271E3GRIACT
CERAMIDE NP4370DF050BIACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
JUNIPERUS DEPPEANA WOOD OIL4739QA5686IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
CETEARYL OLIVATE58B69Q84JOIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ROSEMARYIJ67X351P9IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TROMETHAMINE023C2WHX2VIACT
EUCALYPTUS OIL2R04ONI662IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
GARDENIA JASMINOIDES FRUIT7CTH8MD549IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CYANOCOBALAMINP6YC3EG204IACT
PREZATIDE COPPER6BJQ43T1I9IACT
MALTODEXTRIN7CVR7L4A2DIACT
CENTELLA ASIATICA7M867G6T1UIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYGONUM CUSPIDATUM ROOT7TRV45YZF7IACT
SCUTELLARIA BAICALENSIS ROOT7J95K7ID2SIACT
PROPOLIS WAX6Y8XYV2NOFIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SHEA BUTTERK49155WL9YIACT

Complete SPL Sections#

Active Ingridients

OTC - ACTIVE INGREDIENT SECTION

Glycerin (10%) Allantoin (0.001%)

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

DOSAGE & ADMINISTRATION SECTION

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

Warnings

WARNINGS SECTION

For external use only keep away from heat.

When using this product

OTC - WHEN USING SECTION

keep out of eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

INDICATIONS & USAGE SECTION

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

Other Information

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML