SPL v2
SPL
SPL Set ID c9d99147-185e-4733-8fbc-f10781c729c5
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (3.0 g) Allantoin (0.5 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-09-01

Description

Active ingredients: Dimethicone 3.0%, Allantoin 0.5%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Dimethicone 3.0%, Allantoin 0.5%

Uses

Uses: NEWSTEM Rx Fractional Cream helps sensitive and damaged skin to protect, moisturize and rest.

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.

Directions

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

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

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses: NEWSTEM Rx Fractional Cream helps sensitive and damaged skin to protect, moisturize and rest.

Purpose (PURPOSE)

Purpose: Skin Protectant

Warnings (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.

Directions

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

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Dimethicone 3.0%, Allantoin 0.5%

Inactive Ingredient (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

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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