Face Reality 10% Advanced Acne Med

Face Reality 10% Advanced Acne Med
SPL v1
SPL
SPL Set ID a214ea15-6346-4729-ba84-fbc842faf92a
Route
TOPICAL
Published
Effective Date 2024-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 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 10%

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Benzoyl Peroxide 10%

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 produt. 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 10%

Do Not Use If You
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Package Labeling:

Other Information:
  • Store at room temperature of 68-77 F (22-25 C).
Inactive Ingredients:

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

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 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, whuch 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 produt. 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 10%

Do Not Use If You (Do not use if you)
  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide
Package Labeling:

Other Information: (Other information:)
  • Store at room temperature of 68-77 F (22-25 C).
Inactive Ingredients: (Inactive ingredients:)

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

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 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, whuch 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

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