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DERMOESSENTIAL SUPER ENZYME

Dosage form: powder
Ingredients: Allantoin 0.02g in 50g
Labeler: DMS INTERNATIONAL CO., LTD.
NDC Code: 70265-070

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENT

Active Ingredient: Allantoin 0.05%

INACTIVE INGREDIENT

Inactive Ingredients: Zea Mays (Corn) Starch, Disodium Lauryl Sulfosuccinate, Sodium Myristoyl Glutamate, Sodium Palmate, Sodium Palmoyl Glutamate, Sodium Lauroyl Glutamate, Hydroxypropyl Methylcellulose, Xylitol, Salix Alba (Willow) Bark Extract, Sodium Ascorbyl Phosphate, Maltodextrin, Papain

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.

KEEP OUT OF REACH OF CHILDREN

Keep product out of reach of infants and children.

INDICATIONS & USAGE

Indications & usage: Pour palm with 0.5-1.0g powder add water and emulsify to create a foamly consistency. Apply to face, neck and rinse off.

DOSAGE & ADMINISTRATION

Dosage & Administration: Use immediately after opening

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DERMOESSENTIAL SUPER ENZYME 
allantoin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70265-070
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (ALLANTOIN) Allantoin0.02 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
Sodium Palmate 
Packaging
#Item CodePackage Description
1NDC:70265-070-0150 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2016
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIOperations
DMS INTERNATIONAL CO., LTD.688309194repack(70265-070)
Establishment
NameAddressID/FEIOperations
Cosmecca Korea Co., Ltd.688830827manufacture(70265-070)

Revised: 03/2016
 
DMS INTERNATIONAL CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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