Hydro H
FDA Label NDC 69422-5001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by General Bio Co., Ltd. for the product Hydro H (NDC 69422-5001). 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 otc - active ingredient, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

arbutin

Inactive Ingredient

water, hyaluronic acid,copper tripeptide-1, tripeptide-29, ginsenosides, etc


Otc - Purpose

skin whitening
skin protectant



Otc - Keep Out Of Reach Of Children

keep out of reach of the children

Indications & Usage

apply proper amount to the skin


Warnings

・Stop using the product when you have skin problems or the product disagrees with your skin
・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
・If the product gets into the eyes, don't rub but rinse with water.
・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


Dosage & Administration

for external use only

* Please review the disclaimer below.