repuera DermAtozyme 5% Hydro Essential Ampule

Manufacturer
ALLUV
Effective date
2021-01-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:47

Label at a glance#

Productrepuera DermAtozyme 5% Hydro Essential Ampule
Active ingredientGLYCERIN, ALLANTOIN
Label structure11 sections

Indications and uses

Organizing water-oil balance. Micro-encapsulated oil and water gives glow and balances to the broken skin barrier.

Dosage and administration

Apply an appropriate amount of drops to the damaged skin and massage in as a leave on treatment. Gently tap for absorption. Use daily or as often as needed.

Storage and handling

STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

Active Ingridients

OTC - ACTIVE INGREDIENT SECTION

Glycerin (15%)

Allantoin (0.01%)

Purpose

OTC - PURPOSE SECTION

skin protectant

Uses

DOSAGE & ADMINISTRATION SECTION

Organizing water-oil balance.
Micro-encapsulated oil and water gives glow and balances
to the broken skin barrier.

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 an appropriate amount of drops
to the damaged skin and massage in as a leave on treatment.
Gently tap for absorption. Use daily or as often as needed.

Other Information

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

81459-303-0181459-303-01

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81459-303-012022-07-29C16284748780-1e4f33bdf-b347-d8a0-e053-dadaa90a6e4e81459-303 re'puera DermAtozyme 5% Hydro Essential Ampule

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81459-303-01repuera DermAtozyme 5% Hydro Essential Ampule50 mL in 1 AMPULELIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81459-303REPUERA DERMATOZYME 5% HYDRO ESSENTIAL AMPULE (ALLANTOIN, GLYCERIN) LIQUID [ALLUV]1Legacy NDC, 1 package rows20210307_b9f242f2-8e31-7a23-e053-2a95a90afcaf.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81459-30381459-303-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b9f242f2-8e32-7a23-e053-2a95a90afcafb9f242f2-8e31-7a23-e053-2a95a90afcaf2021-01-28WarningsExact identifier
spl id: b9f242f2-8e32-7a23-e053-2a95a90afcaf
spl set id: b9f242f2-8e31-7a23-e053-2a95a90afcaf

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.