FDA Label for Game Over Acne Drying Treatment

View Indications, Usage & Precautions

Game Over Acne Drying Treatment Product Label

The following document was submitted to the FDA by the labeler of this product Offspring Beauty Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

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


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.


Otc - When Using



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.

Otc - Do Not Use



Do not use on

  • broken skin
  • large areas of the skin.

Otc - 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.


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.


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


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