Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 3d4ef4ce-9be3-436a-9f93-c01caa93d1a8
Route
TOPICAL
Published
Effective Date 2026-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (0.025 g)
Inactive Ingredients
Water Glycereth-18 Ethylhexanoate Glycereth-18 Hexamethyldisiloxane Glycerin Butylene Glycol Propanediol Acrylamide/sodium Acryloyldimethyltaurate Copolymer (120000 Mpa.s At 1%) Allantoin Ascorbyl Palmitate Levomenol Myristyl Alcohol Pidolic Acid Phytosteryl/octyldodecyl Lauroyl Glutamate Reynoutria Japonica Root Hyaluronate Sodium Ginger Polyacrylic Acid (800000 Mw) Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Cetyl Hydroxyethylcellulose (350000 Mw) Hydroxyphenyl Propamidobenzoic Acid Polyglyceryl-2 Isostearate Polysorbate 80 Sorbitan Monooleate Xanthan Gum Docusate Sodium Isohexadecane Dimethyl Isosorbide Tocopherol Citric Acid Monohydrate Sodium Citrate, Unspecified Form Sodium Hydroxide Caprylyl Glycol Decylene Glycol Hexylene Glycol Pentylene Glycol 1,2-hexanediol Ethylhexylglycerin Hydroxyacetophenone Phenoxyethanol Citral .beta.-citronellol, (r)- Limonene, (+/-)- Linalool, (+/-)- Carvone, (+/-)- Bitter Orange Oil Spearmint Oil Pinene Mica Stannic Oxide Titanium Dioxide Fd&c Blue No. 1 Ext. D&c Violet No. 2 D&c Red No. 33

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 and 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
Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • dispense 1-2 pumps and cover the entire affected area with a thin, even layer one to three times daily
  • do not rinse product off face
  • wash hands after application to help avoid staining fabrics
  • 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.

Questions?

1-888-995-5656

Active Ingredient

Benzoyl peroxide 2.5%

Other Information

store between 15-30°C (59-86°F)

Inactive Ingredients

water/aqua/eau, glycereth-18 ethylhexanoate, glycereth-18, disiloxane, glycerin, butylene glycol, propanediol, acrylamide/sodium acryloyldimethyltaurate copolymer, allantoin, ascorbyl palmitate, bisabolol, myristyl alcohol, PCA, phytosteryl/octyldodecyl lauroyl glutamate, polygonum cuspidatum root extract, sodium hyaluronate, zingiber officinale (ginger) root extract, fragrance/parfum, carbomer, methyl methacrylate crosspolymer, cetyl hydroxyethylcellulose, hydroxyphenyl propamidobenzoic acid, polyglyceryl-2 isostearate, polysorbate 80, sorbitan oleate, xanthan gum, diethylhexyl sodium sulfosuccinate, isohexadecane, dimethyl isosorbide, tocopherol, citric acid, sodium citrate, sodium hydroxide, caprylyl glycol, decylene glycol, hexylene glycol, pentylene glycol, 1,2-hexanediol, ethylhexylglycerin, hydroxyacetophenone, phenoxyethanol, citral, citronellol, limonene, linalool, carvone, citrus aurantium peel oil, mentha viridis (spearmint) leaf oil, pinene, mica, tin oxide, titanium dioxide (CI 77891), blue 1 (CI 42090), ext. violet 2 (CI 60730), red 33 (CI 17200)

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 50 Ml Tube Label

RODAN+FIELDS

SPOTLESS

ACNE

CLEARING

TREATMENT

2

Principal Display Panel 50 Ml Carton Label

RODAN+FIELDS

SPOTLESS

ACNE CLEARING TREATMENT

Benzoyl Peroxide Lotion*

50 mL / 1.7 Fl. Oz U.S.


Structured Label Content

Uses
  • for the treatment of acne
  • helps keep skin clear of new acne blemishes, acne pimples, blackheads and 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
Purpose

Acne treatment

Warnings

For external use only

Directions
  • clean the skin thoroughly before applying this product
  • dispense 1-2 pumps and cover the entire affected area with a thin, even layer one to three times daily
  • do not rinse product off face
  • wash hands after application to help avoid staining fabrics
  • 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.

Questions?

1-888-995-5656

Active Ingredient (Active ingredient)

Benzoyl peroxide 2.5%

Other Information (Other information)

store between 15-30°C (59-86°F)

Inactive Ingredients (Inactive ingredients)

water/aqua/eau, glycereth-18 ethylhexanoate, glycereth-18, disiloxane, glycerin, butylene glycol, propanediol, acrylamide/sodium acryloyldimethyltaurate copolymer, allantoin, ascorbyl palmitate, bisabolol, myristyl alcohol, PCA, phytosteryl/octyldodecyl lauroyl glutamate, polygonum cuspidatum root extract, sodium hyaluronate, zingiber officinale (ginger) root extract, fragrance/parfum, carbomer, methyl methacrylate crosspolymer, cetyl hydroxyethylcellulose, hydroxyphenyl propamidobenzoic acid, polyglyceryl-2 isostearate, polysorbate 80, sorbitan oleate, xanthan gum, diethylhexyl sodium sulfosuccinate, isohexadecane, dimethyl isosorbide, tocopherol, citric acid, sodium citrate, sodium hydroxide, caprylyl glycol, decylene glycol, hexylene glycol, pentylene glycol, 1,2-hexanediol, ethylhexylglycerin, hydroxyacetophenone, phenoxyethanol, citral, citronellol, limonene, linalool, carvone, citrus aurantium peel oil, mentha viridis (spearmint) leaf oil, pinene, mica, tin oxide, titanium dioxide (CI 77891), blue 1 (CI 42090), ext. violet 2 (CI 60730), red 33 (CI 17200)

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 50 Ml Tube Label (Principal Display Panel - 50 mL Tube Label)

RODAN+FIELDS

SPOTLESS

ACNE

CLEARING

TREATMENT

2

Principal Display Panel 50 Ml Carton Label (Principal Display Panel - 50 mL Carton Label)

RODAN+FIELDS

SPOTLESS

ACNE CLEARING TREATMENT

Benzoyl Peroxide Lotion*

50 mL / 1.7 Fl. Oz U.S.


Advanced Ingredient Data


Raw Label Data

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