Rugby ®

Rugby ®
SPL v3
SPL
SPL Set ID b55acec6-5a4d-08b7-e053-2995a90a0f74
Route
TOPICAL
Published
Effective Date 2020-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (50 mg)
Inactive Ingredients
Carboxymethylcellulose Sodium, Unspecified Form Edetate Disodium Laureth-4 Sodium Hydroxide Titanium Dioxide Water

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Acne treatment


Medication Information

Purpose

Acne treatment

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 right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Section 50570-1

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Warnings

For external use only

Directions

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Active Ingredient

Benzoyl peroxide 5%

Other Information

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive Ingredients

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Questions Or Comments?

1-800-645-2158

When Using This Product

n keep away from eyes, lips and mouth

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
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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 right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Section 50570-1 (50570-1)

Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.

Purpose

Acne treatment

Warnings

For external use only

Directions

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

Active Ingredient (Active ingredient)

Benzoyl peroxide 5%

Other Information (Other information)

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive Ingredients (Inactive ingredients)

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Questions Or Comments? (Questions or comments?)

1-800-645-2158

When Using This Product (When using this product)

n keep away from eyes, lips and mouth

  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
  • using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
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Advanced Ingredient Data


Raw Label Data

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