SPL v2
SPL
SPL Set ID 80267eab-421b-4386-bf95-aa584120a816
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (4.0 g) Allantoin (1.0 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

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

Description

Active ingredients: Dimethicone 2.0%, Allantoin 0.5%

Purpose

Purpose: Skin Protectant


Medication Information

Purpose

Purpose: Skin Protectant

Description

Active ingredients: Dimethicone 2.0%, Allantoin 0.5%

Uses

Uses: NEWSTEM Rx Ceramide Lotion helps sensitive and dry skin to moisturize, rest and protect.

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 2.0%, Allantoin 0.5%

Inactive Ingredient

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

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses: NEWSTEM Rx Ceramide Lotion helps sensitive and dry skin to moisturize, rest and protect.

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 2.0%, Allantoin 0.5%

Inactive Ingredient (INACTIVE INGREDIENT)

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

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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