SEUK- allantoin soap 
NANOPOLY CO., LTD.

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.

----------

ACTIVE INGREDIENT

Active ingredient: Allantoin 0.6%

INACTIVE INGREDIENT

Inactive ingredients:
Coconut and Palm (Kernel/Oil), Jojoba Oil, Eriocephalus Punctulatus Oil, Phytosqualane, Grape Seed Oil, Tea Tree Oil, Aloe Barbadensis Leaf Extract, Tocopherol, Oriental Herb Extract, Perfume, Colloidal Silver, Organic Germanium, Organic Selenium, Platinum

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: Don't use if redness or irritation occur.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children: Keep out of reach of babies and children.

INDICATIONS AND USAGE

Indication and usage: Do not place a lot of water or moisture before and after use.

DOSAGE AND ADMINISTRATION

Dosage and administration: Made enough foam with hands and rubbed on the face or body, and washing with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SEUK 
allantoin soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54170-130
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin 0.6 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
COCONUT OIL (UNII: Q9L0O73W7L)  
JOJOBA OIL (UNII: 724GKU717M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54170-130-01 100 g in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/01/2014
Labeler - NANOPOLY CO., LTD. (687162537)
Registrant - NANOPOLY CO., LTD. (687162537)
Establishment
Name Address ID/FEI Business Operations
NANOPOLY CO., LTD. 687162537 manufacture(54170-130)

Revised: 3/2014
Document Id: 159a304b-2122-4957-acb6-8bec2d094f0b
Set id: 49aaa97b-b91b-4522-8c55-b3286b41d56c
Version: 1
Effective Time: 20140326
 
NANOPOLY CO., LTD.