Pedatosol
FDA Label NDC 73113-010

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mh Global Co., Ltd. for the product Pedatosol (NDC 73113-010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, inactive ingredient, purpose, warnings, keep out of reach of children, uses, directions, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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.

* Please review the disclaimer below.