Face Reality Advanced Acne Med

Face Reality Advanced Acne Med
SPL v1
SPL
SPL Set ID e1eb8496-0611-4dbc-befb-fb43ec164433
Route
TOPICAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (25 mg)
Inactive Ingredients
Water Glycerin Propanediol Hyaluronate Sodium Levomenol Carbomer Homopolymer, Unspecified Type Ammonium Acryloyldimethyltaurate/vp Copolymer Xanthan Gum Sodium Hydroxide Phenoxyethanol Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-24

Description

Benzoyl Peroxide 2.5%

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Benzoyl Peroxide 2.5%

Uses
  • For the treatment of acne 
  • Penetrates pores to control acne blemishes, blackheads and whiteheads
  • Helps to keep new acne blemishes from forming
Warnings

For external use only

Directions
  • Cleanse the skin thoroughly before applying product. Cover the affected area(s) 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.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of the product and ask a doctor.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Do Not Use If You
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Other Information:
  • Store at room temperature of 68-77 F (22-25 C).
Package Labelling:

Inactive Ingredients:

Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Bisabolol, Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments?

1-866-477-3077

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. 
  • Avoid unnecessary sun exposure and use a sunscreen
  • Avoid contact with the eyes, lips, and mouth
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product 
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use and Ask A Doctor

if irritation becomes severe.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • For the treatment of acne 
  • Penetrates pores to control acne blemishes, blackheads and whiteheads
  • Helps to keep new acne blemishes from forming
Purpose

Acne Medication

Warnings

For external use only

Directions
  • Cleanse the skin thoroughly before applying product. Cover the affected area(s) 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.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of the product and ask a doctor.
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.
Drug Facts

Active Ingredient

Benzoyl Peroxide 2.5%

Do Not Use If You (Do not use if you)
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Other Information: (Other information:)
  • Store at room temperature of 68-77 F (22-25 C).
Package Labelling:

Inactive Ingredients: (Inactive ingredients:)

Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Bisabolol, Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin.

Questions Or Comments? (Questions or comments?)

1-866-477-3077

When Using This Product (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. 
  • Avoid unnecessary sun exposure and use a sunscreen
  • Avoid contact with the eyes, lips, and mouth
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product 
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation becomes severe.

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

All Sections (JSON)