Rebirth Hair
FDA Label NDC 44781-180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zion Synthetic Fiber Co., Ltd. for the product Rebirth Hair (NDC 44781-180). 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, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredient: PYRITHIONE ZINC

Inactive Ingredient

Inactive ingredients:

Water, Ammonium Laureth Sulfate, Potassium Cocoyl Glycinate, Cocamidopropyl Betaine, Lauramide DEA, Portulaca Oleracea Extract, Propylene Glycol, Copper Tripeptide-1, Panthenol, Diglycerin,  Polyquaternium-10, Pyrrolidinyl Diaminopy-rimidine Oxide, Salicylic Acid, Flavor, Polyquaternium-7, Artemisia Vulgaris Extract, Glycine Soja (Soybean) Extract, Sesamum Indicum (Sesame) Seed Extract,
Oryza Sativa (Bran) Rice Extract, Camellia Japonica Flower Extract, Morus Alba Root Extract, Polygonum Multiflorum Root Extract, Citric Acid, Hematite Extract, Aluminum Silicate, Topaz, Zeolite,  Tourmaline, Tetrasodium EDTA, Disodium EDTA, Methylchloroisothiazolinone Methylisothiazolinone

Otc - Purpose

Purpose:

Effects for the damaged hair
Removes dandruff, antifungal, itching, and waste matter on the scalp

Warnings

Warnings:
In case of having following symptoms after using this, you're advised to stop using it immediately.  If you keep using it,  the  symptoms will get worse and need to consult a dermatologist.
- In case of having problems such as red rash, swollenness, itching, stimulation during usage.
- In case of having the same symptoms above on the part you put this product on by direct sunlight.
You are banned to use it on the part where you have a scar, eczema, or dermatitis.
In case of getting it into your eyes, you have to wash it immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children:
Keep out of the reach of babies and children.

Indications & Usage

Indication and usage:
Tighten the lid after using it.
Don't keep it in the place where the temperature is extremely hot or low and exposed the direct sunlight.    
Massage the scalp while washing hair and rinse out fully.
Wash your hair for about 2 minutes.
Please shampoo everyday or every other day.

Dosage & Administration

Dosage and administration:
Take up about one quarter dollar coin of it and put it on palms, and rub it having enough foam and shampoo.

* Please review the disclaimer below.