PEDATOSOL- oatmeal solution

PEDATOSOL by

Drug Labeling and Warnings

PEDATOSOL by is a Otc medication manufactured, distributed, or labeled by Mh Global Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Colloidal Oatmeals 4.28 %

INACTIVE INGREDIENT

Inactive ingredients:

Lactobacillus Ferment Extract, Water, Cocos Nucifera (Coconut) Oil, 1,2-Hexanediol, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Beta-Glucan, Citrus Grandis (Grapefruit) Seed Extract

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:

For external use only.

When Using this Do not get into eyes. - In case of the following symptoms, you should cease usage; if the symptoms get worse due to the continued use, visit the professionals for consulting
- In case of any abnormal symptoms or side effects such as red spots, swelling or itching by direct sunlight, visit a specialist for consulting when using or after usage. Do not use on wounded sites, from external natures. Keep out of reach of children. Store at room temperature.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

Helps Skin Moisturization and Reproduction of the Childs with Pediatric dermatitis, including atopic dermatitis.

Directions

Directions:

To expect outstanding improvements, please consistently apply the sufficient amount of the solution for two-three times per day at least. That does not mean that you mustn’t use it more than the above dates and procedures.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDATOSOL 
oatmeal solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73113-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Oatmeal (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	Oatmeal	2.99 g  in 70 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73113-010-01	70 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/01/2019

Labeler - Mh Global Co., Ltd. (694470757)

Registrant - Mh Global Co., Ltd. (694470757)

Establishment
Name	Address	ID/FEI	Business Operations
Aju cosmetic Co., Ltd.		689847363	manufacture(73113-010)