Drug Labeling and Warnings

Drug Details [pdf]

DERMOESSENTIAL SUPER ENZYME- allantoin powder 
DMS INTERNATIONAL CO., LTD.

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.

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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

Image of carton

DERMOESSENTIAL SUPER ENZYME 
allantoin powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70265-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.02 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
Sodium Palmate (UNII: S0A6004K3Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70265-070-0150 g in 1 CARTON; Type 0: Not a Combination Product02/01/201601/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/201601/02/2019
Labeler - DMS INTERNATIONAL CO., LTD. (688309194)
Registrant - DMS INTERNATIONAL CO., LTD. (688309194)
Establishment
NameAddressID/FEIBusiness Operations
DMS INTERNATIONAL CO., LTD.688309194manufacture(70265-070)

Revised: 8/2019