drug facts

drug facts
SPL v5
SPL
SPL Set ID 8f7bb793-3c60-4014-954e-514ef87a44fb
Route
topical
Published
Effective Date 2026-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzoyl peroxide (0.05 g)
Inactive Ingredients
water polyacrylamide (10000 mw) c13-14 isoparaffin carboxypolymethylene cocamidopropyl betaine docusate sodium ethylhexylglycerin hydrogenated jojoba oil, randomized laureth-7 phenoxyethanol propanediol sodium benzoate sodium chloride sodium citrate, unspecified form sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-02-13

Purpose

Acne treatment

Description

Benzoyl peroxide 5%


Medication Information

Warnings

For external use only

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

Acne treatment

Directions
  • wet skin with lukewarm water
  • using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes
  • rinse thoroughly and pat dry
  • use once daily and increase to twice daily as tolerated
  • 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.
Other Information

store between 15-30°C (59-86°F)

Inactive Ingredients

water, polyacrylamide, C13-14 isoalkane, jojoba esters, carbomer, diethylhexyl sodium sulfosuccinate, cocamidopropyl betaine, laureth-7, sodium chloride, sodium citrate, sodium hydroxide, propanediol, ethylhexylglycerin, phenoxyethanol, sodium benzoate

Description

Benzoyl peroxide 5%

Questions?

1-888-995-5656

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
Active Ingredient

Benzoyl peroxide 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 125 Ml Tube Label

RODAN+FIELDS

SPOTLESS

DAILY

ACNE

WASH

1

Principal Display Panel 125 Ml Carton Label

RODAN+FIELDS

SPOTLESS

DAILY

ACNE

WASH

1

125 mL/4.2 Fl. Oz. U.S.


Structured Label Content

Warnings

For external use only

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

Acne treatment

Directions
  • wet skin with lukewarm water
  • using fingertips, apply a thin, even layer and massage over entire face for 90 seconds, avoiding all contact with eyes
  • rinse thoroughly and pat dry
  • use once daily and increase to twice daily as tolerated
  • 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.
Other Information (Other information)

store between 15-30°C (59-86°F)

Inactive Ingredients (Inactive ingredients)

water, polyacrylamide, C13-14 isoalkane, jojoba esters, carbomer, diethylhexyl sodium sulfosuccinate, cocamidopropyl betaine, laureth-7, sodium chloride, sodium citrate, sodium hydroxide, propanediol, ethylhexylglycerin, phenoxyethanol, sodium benzoate

Questions?

1-888-995-5656

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
Active Ingredient (Active ingredient)

Benzoyl peroxide 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 125 Ml Tube Label (Principal Display Panel - 125 mL Tube Label)

RODAN+FIELDS

SPOTLESS

DAILY

ACNE

WASH

1

Principal Display Panel 125 Ml Carton Label (Principal Display Panel - 125 mL Carton Label)

RODAN+FIELDS

SPOTLESS

DAILY

ACNE

WASH

1

125 mL/4.2 Fl. Oz. U.S.


Advanced Ingredient Data


Raw Label Data

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