Humane Acne Spot Treatment Gel

Humane Acne Spot Treatment Gel
SPL v3
SPL
SPL Set ID ceeb398e-c516-45e4-a21c-cbecf6206fcc
Route
TOPICAL
Published
Effective Date 2021-02-22
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 Caprylyl Glycol Cucumber Licorice Hexylene Glycol Menthyl Lactate, (-)- Phenoxyethanol Polysorbate 20 Potassium Sorbate Propylene Glycol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Benzoyl Peroxide 5%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Benzoyl Peroxide 5%

Use

for the treatment of acne.

Warnings

For external use only.

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.
Drug Facts

Questions?

thehumanecompany.com

Active Ingredient

Benzoyl Peroxide 5%

Do Not Use If You
  • are sensitive to benzoyl peroxide 
  • have very sensitive skin.
Package Labeling:

Inactive Ingredients

a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Caprylyl Glycol, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Menthyl Lactate, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Sodium Hydroxide

When Using This Product
  • Skin irritation and dryness are 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 eyes, lips and mouth. Avoid product 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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children:

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


Structured Label Content

Use

for the treatment of acne.

Purpose

Acne Treatment

Warnings

For external use only.

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.
Drug Facts

Questions?

thehumanecompany.com

Active Ingredient (Active ingredient)

Benzoyl Peroxide 5%

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

Inactive Ingredients (Inactive ingredients)

a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Caprylyl Glycol, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Menthyl Lactate, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Sodium Hydroxide

When Using This Product (When using this product)
  • Skin irritation and dryness are 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 eyes, lips and mouth. Avoid product 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.

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

ask a health professional before use.

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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