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

----------

81459-301 re'puera DermAtozyme 5% Gauze Dressing Mask

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

81459-301-01

REPUERA DERMATOZYME 5% GAUZE DRESSING MASK 
glycerin, allantoin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81459-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 mg  in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81459-301-0118 mL in 1 POUCH; 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(81459-301)

Revised: 1/2021
Document Id: b9f02209-c672-efd6-e053-2995a90a1b3a
Set id: b9f02209-c671-efd6-e053-2995a90a1b3a
Version: 1
Effective Time: 20210128
 
ALLUV