REPUERA DERMATOZYME 5% HYDRO ESSENTIAL AMPULE- allantoin, glycerin 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.

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81459-303 re'puera DermAtozyme 5% Hydro Essential Ampule

Active Ingridients

Glycerin (15%)

Allantoin (0.01%)

Purpose

skin protectant

Uses

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

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 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

STORE AT ROOM TEMPERATURE

Inactive Ingredients

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

81459-303-01

REPUERA DERMATOZYME 5% HYDRO ESSENTIAL AMPULE 
allantoin, glycerin liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81459-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN15 mg  in 100 mL
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.01 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CYANOCOBALAMIN (UNII: P6YC3EG204)  
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
DIPHENYL DIMETHICONE (100 CST) (UNII: AG1ANB6B8O)  
CHAMOMILE (UNII: FGL3685T2X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
POLYGONUM CUSPIDATUM ROOT (UNII: 7TRV45YZF7)  
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
VALYLTRYPTOPHAN (UNII: 3G64B4AFQN)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SAGE OIL (UNII: U27K0H1H2O)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GERANIOL (UNII: L837108USY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
CERAMIDE NP (UNII: 4370DF050B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PREZATIDE (UNII: 39TG2H631E)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
RICE GERM (UNII: 7N2B70SFEZ)  
ROSEMARY (UNII: IJ67X351P9)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81459-303-0150 mL in 1 AMPULE; 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(81459-303)

Revised: 1/2021
Document Id: b9f242f2-8e32-7a23-e053-2a95a90afcaf
Set id: b9f242f2-8e31-7a23-e053-2a95a90afcaf
Version: 1
Effective Time: 20210128
 
ALLUV