Acne Serum Medicated Treatment

Acne Serum Medicated Treatment
SPL v1
SPL
SPL Set ID ff0b2dc9-c371-4bb6-e053-6394a90aefad
Route
TOPICAL
Published
Effective Date 2023-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (3 mg)
Inactive Ingredients
Niacinamide Cetostearyl Alcohol C15-19 Alkane Dimethyl Isosorbide Coconut Alkanes Medium-chain Triglycerides Coco-caprylate Limosilactobacillus Fermentum Tranexamic Acid Bakuchiol Potassium Azeloyl Diglycinate Glycerin Docosanol Soybean Oil 1,2-hexanediol Sodium Stearoyl Lactylate Hexyl Laurate Glyceryl Monostearate Hydrogenated Polydecene Type I Candelilla Wax Water Propanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-06-26

Description

Salicylic Acid

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Salicylic Acid

Uses

Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming

Section 51945-4

Warnings

For external use only

Directions

Clean the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer morning and night for best results.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Active Ingredient

Salicylic Acid

Other Information

Store at 20 - 25C (68-77F)

Inactive Ingredient

Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.

When Using Use Only

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Treats Acne and helps skin heal. Penetrates pores to eliminate most acne blemishes and blackheads. Helps prevent new acne blemishes and blackheads from forming

Section 51945-4 (51945-4)

Purpose

Acne Medication

Warnings

For external use only

Directions

Clean the skin thoroughly before applying this product.

Cover the entire affected area with a thin layer morning and night for best results.

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Active Ingredient

Salicylic Acid

Other Information (Other information)

Store at 20 - 25C (68-77F)

Inactive Ingredient

Water/Aqua, Propanediol, Glycerin, Caprylic/Capric Triglyceride, Dimethyl Isosorbide, Lactobacillus Ferment, Coconut Alkanes, Coco-Caprylate, Niacinamide, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Tranexamic Acid, Hexyl Laurate, Glycine Soja Soybean, C15-19 Alkane, Potassium Azeloyl Diglycinate, Hydrogenated Polydecene, Glyceryl Stearate, Ceramide NP, Ceramide AP, Bakuchiol, Fucus Spiralis Extract, Rhodomyrtus Tomentosa Fruit Extract, Tasmannia Lanceolata Fruit/Leaf Extract, Acetyl Glucosamine, Hydrolyzed Sodium Hyaluronate, Zinc Sulfate, Melia Azadirachta Leaf Extract, Centella Asiatica Leaf Extract, Silybum Marianum Seed Extract, Vitex Agnus - Castus Extra, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Allantoin, Panthenol, 1,2 - Hexanediol, Sodium Stearoyl Lactylate, Citric Acid, Xanthan Gum, Polyglyceryl - 3 Diisostearate, Polyacrylate Crosspolymer - 6, Coco - Caprylate/Caprate, Caprylhydroxamic Acid, Sodium Phytate, Tocopherol, Sodium Benzoate, Potassium Sorbate, Biosaccaharide Gum - 1, Phenoxyethanol, Sodium Anisate.

When Using Use Only (When using use only)

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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