Game Over Acne Drying Treatment

Game Over Acne Drying Treatment
SPL v4
SPL
SPL Set ID dfff2d54-d0da-483f-9d40-60f25c108556
Route
TOPICAL
Published
Effective Date 2024-01-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (100 mg)
Inactive Ingredients
Water Kaolin Propanediol Bentonite Silicon Dioxide Tetrahexyldecyl Ascorbate Pentylene Glycol Butylene Glycol Phenoxyethanol Glycerin Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Ammonium Acryloyldimethyltaurate/vp Copolymer Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Glycyrrhizinate Dipotassium Hydrogenated Polybutene (1300 Mw) Ceramide Np Citric Acid Monohydrate Lecithin, Soybean Polyglyceryl-10 Stearate Sodium Benzotriazolyl Butylphenol Sulfonate Sunflower Oil Ethylhexylglycerin Hydroxyphenyl Propamidobenzoic Acid Tetrasodium Glutamate Diacetate Kakadu Plum Podocarpus Elatus Fruit Pleiogynium Timoriense Fruit Zinc Oxide Tert-butyl Alcohol Ascorbyl Palmitate Sodium Hydroxide Tocopherol Sodium Glycolate Sodium Formate

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-01

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Drug Facts

Uses
  • for the management of acne
  • dries and clears acne blemishes, acne pimples, blackheads, and allows skin to heal
  • helps prevent the development of new acne blemishes, acne pimples and blackheads
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.
Section 50570-1

Do not use on

  • broken skin
  • large areas of the skin.
Warnings

For external use only.

Directions
  • clean skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above.
Active Ingredient

Sulfur 10%

Inactive Ingredients

Water/Aqua/Eau, Kaolin, Propanediol, Bentonite, Silica, Tetrahexyldecyl Ascorbate, Pentylene Glycol, Butylene Glycol, Phenoxyethanol, Glycerin, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylates Copolymer, Dipotassium Glycyrrhizate, Hydrogenated Polyisobutene, Zinc Oxide (CI 77947), Ceramide NP, Citric Acid, Phospholipids, Polyglyceryl-10 Stearate, Sodium Benzotriazolyl Butylphenol Sulfonate, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Hydroxyphenyl Propamidobenzoic Acid, Tetrasodium Glutamate Diacetate, Terminalia Ferdinandiana Fruit Extract, t-Butyl Alcohol, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Ascorbyl Palmitate, Sodium Hydroxide, Tocopherol, Sodium Glycolate, Sodium Formate.

Principal Display Panel 15 Ml Tube Carton

10% SULFUR

ACNE TREATMENT

VERSED

GAME OVER

ACNE DRYING TREATMENT

bentonite + kaolin clay

0.5 fl. oz. | 15 ml


Structured Label Content

Uses
  • for the management of acne
  • dries and clears acne blemishes, acne pimples, blackheads, and allows skin to heal
  • helps prevent the development of new acne blemishes, acne pimples and blackheads
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • apply only to areas with acne.
Section 50570-1 (50570-1)

Do not use on

  • broken skin
  • large areas of the skin.
Purpose

Acne treatment

Warnings

For external use only.

Directions
  • clean skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above.
Active Ingredient (Active ingredient)

Sulfur 10%

Inactive Ingredients (Inactive ingredients)

Water/Aqua/Eau, Kaolin, Propanediol, Bentonite, Silica, Tetrahexyldecyl Ascorbate, Pentylene Glycol, Butylene Glycol, Phenoxyethanol, Glycerin, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylates Copolymer, Dipotassium Glycyrrhizate, Hydrogenated Polyisobutene, Zinc Oxide (CI 77947), Ceramide NP, Citric Acid, Phospholipids, Polyglyceryl-10 Stearate, Sodium Benzotriazolyl Butylphenol Sulfonate, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Hydroxyphenyl Propamidobenzoic Acid, Tetrasodium Glutamate Diacetate, Terminalia Ferdinandiana Fruit Extract, t-Butyl Alcohol, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Ascorbyl Palmitate, Sodium Hydroxide, Tocopherol, Sodium Glycolate, Sodium Formate.

Principal Display Panel 15 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton)

10% SULFUR

ACNE TREATMENT

VERSED

GAME OVER

ACNE DRYING TREATMENT

bentonite + kaolin clay

0.5 fl. oz. | 15 ml


Advanced Ingredient Data


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