GAME OVER ACNE DRYING TREATMENT- sulfur cream

Game Over Acne Drying Treatment by

Drug Labeling and Warnings

Game Over Acne Drying Treatment by is a Otc medication manufactured, distributed, or labeled by Offspring Beauty Co., KDC/One Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sulfur 10%

Purpose

Acne treatment

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

Warnings

For external use only.

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.

Do not use on

• broken skin
• large areas of the skin.

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

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.

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.

SPL UNCLASSIFIED SECTION

Dist. by Offspring Beauty Co.
West Hollywood, CA 90069

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

INGREDIENTS AND APPEARANCE

GAME OVER ACNE DRYING TREATMENT 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73690-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
PROPANEDIOL (UNII: 5965N8W85T)
BENTONITE (UNII: A3N5ZCN45C)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CERAMIDE NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)
PLEIOGYNIUM TIMORIENSE FRUIT (UNII: AF3VFG6MLV)
ZINC OXIDE (UNII: SOI2LOH54Z)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM GLYCOLATE (UNII: B75E535IMI)
SODIUM FORMATE (UNII: 387AD98770)

Product Characteristics
Color	GREEN (Leaf Green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73690-026-01	1 in 1 CARTON	07/01/2020
1		15 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	07/01/2020

Labeler - Offspring Beauty Co. (081516405)

Establishment
Name	Address	ID/FEI	Business Operations
KDC/One Chatsworth, Inc.		118542196	MANUFACTURE(73690-026)