Rugby®

Rugby®
SPL v14
SPL
SPL Set ID 98e1bf69-ef71-4e38-8357-54c60d9d03df
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Cellulose Gum Edetate Disodium Laureth-4 Sodium Hydroxide Ci 77891 Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-01-20

Description

Drug Facts

Purpose

Acne medication

How Supplied

Product: 50090-1792 NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON


Medication Information

Purpose

Acne medication

How Supplied

Product: 50090-1792

NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON

Description

Drug Facts

Use

for the treatment of acne

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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.
Benzoyl Peroxide
Active Ingredient

Benzoyl peroxide USP 10%

Do Not Use If You
  • have very sensitive
  • are sensitive to benzoyl peroxide
Other Information
  • keep tightly closed
  • store at room temperature
Inactive Ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions Or Comments?

1-800-645-2158

When Using This Product
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or 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.
  • 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.
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 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

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 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.
How Supplied (HOW SUPPLIED)

Product: 50090-1792

NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON

Benzoyl Peroxide
Active Ingredient (Active ingredient)

Benzoyl peroxide USP 10%

Do Not Use If You (Do not use if you)
  • have very sensitive
  • are sensitive to benzoyl peroxide
Other Information (Other information)
  • keep tightly closed
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions Or Comments? (Questions or comments?)

1-800-645-2158

When Using This Product (When using this product)
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with eyes, lips and mouth
  • avoid contact with hair or 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.
  • 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.
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)