OTC Medication Information: PEDATOSOL

PEDATOSOL- oatmeal solution
Mh Global 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 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

Image of carton
(click image for full-size original)

PEDATOSOL
oatmeal solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73113-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oatmeal (OATMEAL) Oatmeal 2.99 g in 70 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73113-010-01 70 mL in 1 TUBE None
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 Operations
Aju cosmetic Co., Ltd. 689847363 manufacture (73113-010)

Revised: 08/2019 Mh Global Co., Ltd.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2024. All Rights Reserved.