Rebirth Hair Tonic
FDA Label NDC 44781-190

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 Tonic (NDC 44781-190). 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: WITCH HAZEL 0.1%

Inactive Ingredient

Inactive ingredients:
Water, Niacinamide, Panthenol, Dipotassium Glycyrrhizate, Menthol, Pyrrolidinyl Diaminopyrimidine Oxide, Salicylic Acid, Alcohol, Propylene Glycol, Butylene Glycol, Polygonum Multiflorum Root Extract, Portulaca Oleracea Extract, Oryza Sativa (Rice) Extract, Camellia Japonica Flower Extract, Sesamum Indicum (Sesame) Seed Extract, Glycine Max (Soybean) Seed Extract, Morus Alba Bark Extract, Artemisia Vulgaris Extract, Copper Tripeptide-1, PEG-60 Hydrogenated Castor Oil, Phenoxyethanol, Methyl Paraben, Hematite Extract, Aluminum Silicate, Topaz, Zeolite, Tourmaline, Triethanolamine, Disodium EDTA, Flavor

Otc - Purpose

Purpose:
It appears to help to recover the hair damaged.
It appears to make a glossy and elastic hair by preventing the rough and dryness.

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.    
Use it after Rebirth Hair Shampoo.

Dosage & Administration

Dosage and administration:
Pumping it 2-3 drops on scalp of wet hair after shampoo, and massage gently until completely absorbed.

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