NEWSTEM Rx HAIR M by Yj Lab Co., Ltd. / SUANN HYANGJANG.CO.LTD

NEWSTEM Rx HAIR M by

Drug Labeling and Warnings

NEWSTEM Rx HAIR M by is a Otc medication manufactured, distributed, or labeled by Yj Lab Co., Ltd., SUANN HYANGJANG.CO.LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEWSTEM RX HAIR M- rhaphiolepis bibas leaf, saw palmetto solution 
Yj Lab Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS

Eriobotrya Japonica Leaf Extract 0.001%
Serenoa Serrulata Fruit Extract 0.005%

INACTIVE INGREDIENTS- Water Activator

Water, Glycerin, Human Stem Cell Conditioned Media, Butylene Glycol, Pentylene Glycol, Methylparaben, Phenoxyethanol, Sorbitol, Glyco
gen, Potassium Chloride, Magnesium Sulfate, Lecithin, Copper Tripeptide-1, Sodium Phosphate, Mannitol, Pterocarpus Marsupium Bark Extract, Glycine, Disodium Succinate, Ammonium Glycyrrhizate, Glutamic Acid, Serine, Zinc Sulfate, Pyridoxine HCl, Allantoin, 1,2-Hexanediol, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Caffeine, Histidine, Zinc Gluconate, Methionine, Cysteine, AesculusHippocastanum (Horse Chestnut) Seed Extract, Acetic Acid

PURPOSE

Hair Growth
Prevent Hair Loss

WARNINGS

For external use only
1. If the Red swellings such as erythema, itchiness, or irritations because of directly sunlight occur, you must stop using immediately and Consult your dermatologist.
2. Do not apply on skin conditions such as wounds.
3. Storage and Handling.
a. Keep out of the reach of children.
b. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

Uses

■ Helps hair growth

Directions

■ Apply an appropriate amount to the exposed skin when you need.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

Questions

■ www.newstem.co.kr
■ +82-70-5102-0577

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEWSTEM RX HAIR M 
rhaphiolepis bibas leaf, saw palmetto solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71759-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RHAPHIOLEPIS BIBAS LEAF (UNII: Z02066SV11) (RHAPHIOLEPIS BIBAS LEAF - UNII:Z02066SV11)	RHAPHIOLEPIS BIBAS LEAF	0.001 g  in 100 g
SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS)	SAW PALMETTO	0.005 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71759-080-02	10 in 1 CARTON	01/02/2022	11/01/2022
1	NDC: 71759-080-01	5 g in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/02/2022	11/01/2022

Labeler - Yj Lab Co., Ltd. (693900819)

Registrant - Yj Lab Co., Ltd. (693900819)

Establishment
Name	Address	ID/FEI	Business Operations
SUANN HYANGJANG.CO.LTD		688210096	manufacture(71759-080)

Revised: 1/2024

Document Id: d78af49f-6964-41bb-959f-aa31438dc70b

34390-5

Set id: e295779b-f84d-4069-9260-0dc8e5cdc0cc

Version: 2

Effective Time: 20240118