HAIRJOY HAIR ESSENCE by HAIRJOY

HAIRJOY HAIR ESSENCE by

Drug Labeling and Warnings

HAIRJOY HAIR ESSENCE by is a Otc medication manufactured, distributed, or labeled by HAIRJOY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAIRJOY HAIR ESSENCE- allantoin solution 
HAIRJOY

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.

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ACTIVE INGREDIENT

Active ingredient: Allantoin 0.8%

INACTIVE INGREDIENT

Inactive ingredients: Alcohol, Water, Dipropylene Glycol, Artemisia Vulgaris Extract, Curcuma Longa (Turmeric) Root Extract, Angelica Gigas Root Extract, Astragalus Membranaceus Root Extract, Acorus Gramineus Root/Stem Extract, Ginkgo Biloba Leaf Extract, Morus Bombycis Leaf Extract, Panax Ginseng Root Extract, Copper Tripeptide-1, Glycerin, Nonoxynol-12, Triethanolamine, Salicylic Acid, Panthenol, Menthol, Methylparaben, Biotin, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: Precautions for Hair Tonic 1. If you have following symptoms after using cosmetics, please stop using it. If you continue to use it, it may worsen symptoms, consult a dermatologist. 1) If there are symptoms such as redness, swelling, itching, irritation, etc. 2) If there are above symptoms on the application site by sunlight 2. Do not use hair tonic in such a site with wound or eczema and dermatitis. 3. When it gets into the eyes, wash the eyes immediately. 4. Precautions for Storage and Handling 1) Make sure to close the cap after use. 2) Keep out of the reach of infants and children. 3) Keep out of the place with high or low temperature and sunshine.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of infants and children.

INDICATIONS & USAGE

Indications and usage: After shampooing, dry the hair and spray evenly on the scalp, especially on the hair loss area and massage gently with fingers.

DOSAGE & ADMINISTRATION

Dosage and administration: Use twice a day. Use 4 times a day on a site with severe hair loss. 3ml for one-time use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HAIRJOY HAIR ESSENCE 
allantoin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69384-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.96 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69384-030-02	1 in 1 CARTON	10/01/2016	12/01/2018
1	NDC: 69384-030-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/01/2016	12/01/2018

Labeler - HAIRJOY (689060277)

Registrant - HAIRJOY (689060277)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(69384-030)

Revised: 12/2019

Document Id: 6524763d-279f-412d-81d5-081fc5f09f7e

34390-5

Set id: 8248af93-6b28-4da9-8b3f-988c39e20721

Version: 3

Effective Time: 20191209