Rugby ®

Rugby ®
SPL v1
SPL
SPL Set ID 5af89ec6-0f4a-451a-8a45-5194115dc828
Route
TOPICAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Cetearyl Alcohol Citric Acid Edetate Disodium Disodium Laureth Sulfosuccinate Glyceryl Stearate Magnesium Aluminum Silicate Peg-100 Stearate Propylene Glycol Sodium Benzoate Sodium C14-16 Olefin Sulfonate Sodium Lauroamphoacetate Xanthan Gum Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-31

Description

Drug Facts

Purpose

Acne medication


Medication Information

Purpose

Acne medication

Description

Drug Facts

Use

for the treatment of acne

Section 42229-5

Drug Facts

Section 50570-1

Do not use this medication if you

  • have very sensitive skin 
  • are sensitive to benzoyl peroxide.
Section 51945-4

Warnings

For external use only

Directions

• clean the skin thoroughly before applying this product

• cover the entire affected area with a thin layer and rinse thoroughly 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.

Active Ingredient

Benzoyl peroxide USP 10%

Other Information
  • Keep tightly closed
  • Store at room temperature
Inactive Ingredients

Carbomer, Cetearyl Alcohol, Citric Acid, Disodium

EDTA, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, Magnesium

Aluminum Silicate, Peg-100 Stearate, Propylene Glycol, Sodium Benzoate,

Sodium C14-16 Olefin Sulfonate, Sodium Lauroamphoacetate, Xanthan

Gum, Water

Questions Or Comments?

1-866-306-9136

You may also report serious side effects to this phone

number

Mon-Fri, 9:00 AM - 5:00 PM Eastern Time.

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 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.
If Pregnant Or Breastfeeding

ask a health professional before use.

Keep Out of Reach of Children

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

(1-800-222-1222) immediately.

Stop Use and Consult A Doctor If

irritation becomes severe


Structured Label Content

Use

for the treatment of acne

Section 42229-5 (42229-5)

Drug Facts

Section 50570-1 (50570-1)

Do not use this medication if you

  • have very sensitive skin 
  • are sensitive to benzoyl peroxide.
Section 51945-4 (51945-4)

Purpose

Acne medication

Warnings

For external use only

Directions

• clean the skin thoroughly before applying this product

• cover the entire affected area with a thin layer and rinse thoroughly 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.

Active Ingredient (Active ingredient)

Benzoyl peroxide USP 10%

Other Information (Other information)
  • Keep tightly closed
  • Store at room temperature
Inactive Ingredients (Inactive ingredients)

Carbomer, Cetearyl Alcohol, Citric Acid, Disodium

EDTA, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, Magnesium

Aluminum Silicate, Peg-100 Stearate, Propylene Glycol, Sodium Benzoate,

Sodium C14-16 Olefin Sulfonate, Sodium Lauroamphoacetate, Xanthan

Gum, Water

Questions Or Comments? (Questions or comments?)

1-866-306-9136

You may also report serious side effects to this phone

number

Mon-Fri, 9:00 AM - 5:00 PM Eastern Time.

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 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.
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

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

(1-800-222-1222) immediately.

Stop Use and Consult A Doctor If (Stop use and consult a doctor if)

irritation becomes severe


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)