Acne Forte Acne Treatment Cream

Acne Forte Acne Treatment Cream
SPL v2
SPL
SPL Set ID c29ed6c1-b8ad-4131-a94c-379f16ab2ee5
Route
TOPICAL
Published
Effective Date 2021-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Allantoin Aloe Vera Leaf Water Benzyl Alcohol Green Tea Leaf White Tea Orange Oil, Cold Pressed Lemon Dmdm Hydantoin Glycerin Hamamelis Virginiana Root Bark/stem Bark Iodopropynyl Butylcarbamate Methylisothiazolinone Propylene Glycol Polysorbate 20 Salix Nigra Bark Sugarcane Sage Sodium Citrate Hyaluronate Sodium Trolamine Bilberry Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-10

Description

Benzoyl peroxide 5.00%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl peroxide 5.00%

Uses:
  • For the treatment of acne.
Warnings:

For external use only

Questions?

+40 (744) 569 069

Directions:
  • clean the 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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Do Not Use If You
  • have very sensitive skin 
  • are sensitive to benzoyl peroxide.
Package Labeling:

Active Ingredients

Benzoyl peroxide 5.00%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, ALoe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Betula Alba (Brich) Extract, Camellia Sinensis (Green Tea) Extract, camellia Sinensis (White Tea) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Oil, DMDM Hydantoin, Glycerin, Hamamelis Virginiana (Witch Hazel), Iodopropynyl Butylcarbamate, Manuka Honey, Methylisothiazolinone, Parfum (Fragrance), Propylene Glycol, Melaleuca Alternifolia (Tea Tree) Oil, Polysorbate-20, Salix Nigra (Willow) Bark Extract, Saccharum Officinarum (Sugar Cane) Extract, Salvia Officinalis (Sage) Extract, Sodium Citrate, Sodium Hyaluronate, Triethanolamine, Vaccinium Myrtillus (Bilberry Extract, Xanthan Gum.

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 wih 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.

If Pregnant Or Breast Feeding, 

ask a health professional before use


Structured Label Content

Uses:
  • For the treatment of acne.
Purpose

Acne Treatment

Warnings:

For external use only

Questions?

+40 (744) 569 069

Directions:
  • clean the 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.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
Do Not Use If You (Do not use if you)
  • have very sensitive skin 
  • are sensitive to benzoyl peroxide.
Package Labeling:

Active Ingredients (Active ingredients)

Benzoyl peroxide 5.00%

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, ALoe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Betula Alba (Brich) Extract, Camellia Sinensis (Green Tea) Extract, camellia Sinensis (White Tea) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Oil, DMDM Hydantoin, Glycerin, Hamamelis Virginiana (Witch Hazel), Iodopropynyl Butylcarbamate, Manuka Honey, Methylisothiazolinone, Parfum (Fragrance), Propylene Glycol, Melaleuca Alternifolia (Tea Tree) Oil, Polysorbate-20, Salix Nigra (Willow) Bark Extract, Saccharum Officinarum (Sugar Cane) Extract, Salvia Officinalis (Sage) Extract, Sodium Citrate, Sodium Hyaluronate, Triethanolamine, Vaccinium Myrtillus (Bilberry Extract, Xanthan Gum.

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 wih 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 (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.

If Pregnant Or Breast Feeding,  (If pregnant or breast-feeding, )

ask a health professional before use


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Raw Label Data

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