NEWSTEM RX INTENSIVE- allantoin cream

NEWSTEM Rx Intensive by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: Water, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Pentylene Glycol, Dicaprylyl Carbonate, Sucrose Polystearate, Cetyl Ethylhexanoate, Cetearyl Alcohol, BeesWax, Panthenol, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Polyisobutene, Dimethicone, Sodium Polyacrylate, Human Adipocyte Conditioned Media Extract, Mannitol, Phenoxyethanol, Behenyl Alcohol, Citric Acid, Glyceryl Citrate/Lactate/Linoleate/Oleate, Ammonium Glycyrrhizate, Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil, 1,2-Hexanediol, Copper Tripeptide-1, Pisum Sativum (Pea) Extract, Polysorbate 60, Disodium EDTA, Caprylyl Glycol, Tropolone, Caffeine, Sodium Hyaluronate, Zinc Gluconate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ethylhexylglycerin, sh-Decapeptide-9, Galloyl Pentapeptide-33, Caffeoyl sh-Octapeptide-4, sh-Oligopeptide-1, sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-22, rh-Oligopeptide-33

PURPOSE

Purpose: Skin Protectant

WARNINGS

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 REACH OF CHILDREN

Uses

Uses: NEWSTEM Rx Intensive Cream helps sensitive and damaged skin to rest and strong protection.

Directions

Directions: Apply proper amount to sensitive and dry skin after shower. Massage it evenly. Once or twice daily use recommended.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NEWSTEM RX INTENSIVE 
allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71759-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.075 g  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71759-040-02	1 in 1 CARTON	09/01/2017
1	NDC: 71759-040-01	15 mL in 1 TUBE; 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	09/01/2017

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Innogene Co.,Ltd		694396092	manufacture(71759-040)