Active Ingridients
Glycerin (10%)
Allantoin (0.001%)
Repuera Dermatozyme 5% Ultra Moisture Cream
FDA Label NDC 81459-302
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alluv for the product Repuera Dermatozyme 5% Ultra Moisture Cream (NDC 81459-302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingridients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
Uses
pH 5.8 Less-Acid cream. Maintains healthy and smooth skin by providing sufficient nourishment from the inside of 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
Apply the cream to affected area and
massage gently into the skin.
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
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