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.

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.6 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54170-130-01	100 g in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	02/01/2014

Labeler - NANOPOLY CO., LTD. (687162537)

Registrant - NANOPOLY CO., LTD. (687162537)

Name	Address	ID/FEI	Business Operations
Establishment
NANOPOLY CO., LTD.		687162537	manufacture(54170-130)