NEWSTEM RX FRACTIONAL- dimethicone, allantoin cream

NEWSTEM Rx Fractional by

Drug Labeling and Warnings

NEWSTEM Rx Fractional 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: Dimethicone 3.0%, Allantoin 0.5%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Caprylic/Capric Triglyceride, Butylene Glycol, Dipropylene Glycol, Pentylene Glycol, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Polysorbate 60, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Sesquioleate, Human Adipocyte Conditioned Media Extract, Sucrose, Phenoxyethanol, Sodium Polyacrylate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Serine, Glyceryl Citrate/Lactate/Linoleate/Oleate, Behenyl Alcohol, Arginine, PCA, Tocopheryl Acetate, Olea Europaea (Olive) Fruit Oil, Mannitol, Alanine, Sodium Hyaluronate, 1,2-Hexanediol, Threonine, Citric Acid, Disodium EDTA, Pisum Sativum (Pea) Extract, Ammonium Glycyrrhizate, Caprylyl Glycol, Tropolone, Rhizophora Mangle Callus Culture Extract, Neofinetia Falcata Callus Culture Extract, Lilium Candidum Callus Culture Extract, Ceramide NP, Copper Tripeptide-1, Ethylhexylglycerin, Caffeine, Mourera Fluviatilis Extract, t-Butyl Alcohol, Zinc Gluconate, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, sh-Decapeptide-9, Galloyl Pentapeptide-33, Caffeoyl sh-Octapeptide-4, Nicotinoyl sh-Pentapeptide-19, Nicotinoyl Tripeptide-1, sh-Oligopeptide-1, sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-22, rh-Oligopeptide-33, rh-Polypeptide-64

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 Fractional Cream helps sensitive and damaged skin to protect, moisturize and rest.

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 FRACTIONAL 
dimethicone, allantoin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71759-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	3.0 g  in 100 mL
Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	Allantoin	0.5 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71759-030-02	1 in 1 CARTON	09/01/2017
1	NDC: 71759-030-01	100 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(71759-030)