REPUERA DERMATOZYME 5% GAUZE DRESSING MASK- glycerin, allantoin liquid

repuera DermAtozyme 5% Gauze Dressing Mask by

Drug Labeling and Warnings

repuera DermAtozyme 5% Gauze Dressing Mask by is a Otc medication manufactured, distributed, or labeled by ALLUV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingridients

Glycerin (2%)

Allantoin (0.1%)

Purpose

skin protectant

Uses

Intensivley cares the weakened skin barrier by providing sufficient hydration and nourishment.
Gauze type of mask has less irritation when attached to the skin and it effectively delivers essence to 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

Lightly cleanse troubled face or body before attach the mask.
Place the mask to desired afrea of the skin. Take off the mask after 10~15 minutes and tap remaining essence gently for absorption.

Other Information

STORE AT ROOM TEMPERATURE

Inactive Ingredients

Water,Dipropylene Glycol ,Butylene Glycol, 1,2-Hexanediol,Dendropanax Morbiferus Extract,Oryza
Sativa (Rice) Extract,Pinus Densiflora Leaf Extract,Centella Asiatica Extract,Polygonum Cuspidatum Root Extract,Scutellaria Baicalensis Root
Extract,Camellia Sinensis Leaf Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Chamomilla Recutita (Matricaria) Flower Extract,Rosmarinus
Officinalis (Rosemary) Leaf Extract,Caprylic/Capric Triglyceride,Hydrogenated Lecithin,
Phytosteryl/Octyldodecyl Lauroyl Glutamate,Ceramide NP (Ceramide 3),Sodium
Hyaluronate,Hydrolyzed Vegetable Protein,Acrylates/C10-30 Alkyl Acrylate
Crosspolymer,Arginine,Coccinia Indica Fruit Extract,Hydroxyethylcellulose,Hydrolyzed
Jojoba Esters,Melia Azadirachta Flower Extract,Maltodextrin ,Salvia Officinalis (Sage)
Oil,Eucalyptus Globulus Leaf Oil, Juniperus Mexicana Oil,Sodium Citrate,Propolis Extract,Citric Acid,Copper
Tripeptide-1,Cyanocobalamin,Polyglyceryl-10 Laurate,Disodium EDTA,Ethylhexylglycerin

Package Label

INGREDIENTS AND APPEARANCE

REPUERA DERMATOZYME 5% GAUZE DRESSING MASK 
glycerin, allantoin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81459-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	0.1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ARGININE (UNII: 94ZLA3W45F)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
SAGE OIL (UNII: U27K0H1H2O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CERAMIDE NP (UNII: 4370DF050B)
RICE GERM (UNII: 7N2B70SFEZ)
PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ROSEMARY (UNII: IJ67X351P9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
EUCALYPTUS OIL (UNII: 2R04ONI662)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
WATER (UNII: 059QF0KO0R)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
CYANOCOBALAMIN (UNII: P6YC3EG204)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)
CHAMOMILE (UNII: FGL3685T2X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81459-301-01	18 mL in 1 POUCH; 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(81459-301)