Label: NEWSTEM RX FRACTIONAL- dimethicone, allantoin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71759-030-01, 71759-030-02 - Packager: Yj Lab Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 10, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEWSTEM RX FRACTIONAL
dimethicone, allantoin creamProduct 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)
