Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 27ea743c-e080-487d-adc5-e31176f5b9fc
Route
TOPICAL
Published
Effective Date 2025-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (0.025 g)
Inactive Ingredients
Water Diethylene Glycol Monoethyl Ether Glycerin Polyacrylamide (10000 Mw) .beta.-citronellol, (r)- Allantoin Aloe Vera Leaf Aminomethylpropanol Benzyl Alcohol Biosaccharide Gum-1 Butylated Hydroxytoluene C13-14 Isoparaffin Carboxypolymethylene Ceramide 1 Ceramide Ap Ceramide Np Cholesterol Edetate Disodium Anhydrous Ethylhexylglycerin Geraniol Laureth-7 Leuconostoc/radish Root Ferment Filtrate Limonene, (+)- Linalool, (+/-)- Matricaria Chamomilla Flowering Top Niacinamide Panthenol Peg-7 Glyceryl Cocoate Phenoxyethanol Phytosphingosine Pomegranate Sodium Lauroyl Lactylate Starch, Corn Xanthan Gum Yucca Glauca Root

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-13

Description

Benzoyl peroxide 2.5%

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

Description

Benzoyl peroxide 2.5%

Uses
  • for the treatment of acne
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads + whiteheads
Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6

Inactive ingredients allantoin, aloe barbadensis leaf juice, aminomethyl propanol, aqua/eau/water, benzyl alcohol, BHT, biosaccharide gum-1, C13-14 isoalkane, carbomer, ceramide AP, ceramide EOP, ceramide NP, chamomilla recutita (matricaria) flower extract, cholesterol, citronellol, corn starch modified, disodium EDTA, ethoxydiglycol, ethylhexylglycerin, fragrance/parfum, geraniol, glycerin, laureth-7, leuconostoc/radish root ferment filtrate, limonene, linalool, niacinamide, panthenol, PEG-7 glyceryl cocoate, phenoxyethanol, phytosphingosine, polyacrylamide, punica granatum fruit extract, sodium lauroyl lactylate, xanthan gum, yucca glauca root extract

Section 53413-1

Questions? 1-888-995-5656

Section 60561-8

Other information store 15-30°C (59-86°F)

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • dispense 1-2 pumps from each side. Blend product evenly.
  • cover the entire affected area with a thin even layer one to three times daily, as needed
  • 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
  • do not rinse product off face
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • wash hands after application to help avoid staining fabrics
Active Ingredient

Benzoyl peroxide 2.5%

When Using 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.
  • 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
Stop Use and Ask A Doctor If
  • irritation becomes severe
Principal Display Panel 45ml / 1.5 Fl. Oz. Tube Label

RODAN+FIELDS

UNBLEMISH

Dual Intensive Acne Treatment

Benzoyl Peroxide

Lotion

3

Principal Display Panel 45ml / 1.5 Fl. Oz. Carton Label

RODAN+FIELDS

UNBLEMISH

DUAL INTENSIVE ACNE TREATMENT

Benzoyl Peroxide Lotion

R+F

2 x 22.5 mL /

2 x 0.76 Fl. Oz. U.S.


Structured Label Content

Uses
  • for the treatment of acne
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads + whiteheads
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
Section 51727-6 (51727-6)

Inactive ingredients allantoin, aloe barbadensis leaf juice, aminomethyl propanol, aqua/eau/water, benzyl alcohol, BHT, biosaccharide gum-1, C13-14 isoalkane, carbomer, ceramide AP, ceramide EOP, ceramide NP, chamomilla recutita (matricaria) flower extract, cholesterol, citronellol, corn starch modified, disodium EDTA, ethoxydiglycol, ethylhexylglycerin, fragrance/parfum, geraniol, glycerin, laureth-7, leuconostoc/radish root ferment filtrate, limonene, linalool, niacinamide, panthenol, PEG-7 glyceryl cocoate, phenoxyethanol, phytosphingosine, polyacrylamide, punica granatum fruit extract, sodium lauroyl lactylate, xanthan gum, yucca glauca root extract

Section 53413-1 (53413-1)

Questions? 1-888-995-5656

Section 60561-8 (60561-8)

Other information store 15-30°C (59-86°F)

Purpose

Acne treatment

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • dispense 1-2 pumps from each side. Blend product evenly.
  • cover the entire affected area with a thin even layer one to three times daily, as needed
  • 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
  • do not rinse product off face
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • wash hands after application to help avoid staining fabrics
Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

When Using This Product (When using 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.
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation becomes severe
Principal Display Panel 45ml / 1.5 Fl. Oz. Tube Label (Principal Display Panel - 45mL / 1.5 Fl. Oz. Tube Label)

RODAN+FIELDS

UNBLEMISH

Dual Intensive Acne Treatment

Benzoyl Peroxide

Lotion

3

Principal Display Panel 45ml / 1.5 Fl. Oz. Carton Label (Principal Display Panel - 45mL / 1.5 Fl. Oz. Carton Label)

RODAN+FIELDS

UNBLEMISH

DUAL INTENSIVE ACNE TREATMENT

Benzoyl Peroxide Lotion

R+F

2 x 22.5 mL /

2 x 0.76 Fl. Oz. U.S.


Advanced Ingredient Data


Raw Label Data

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