Rugby Benzoyl Peroxide Lotion
FDA Label NDC 0536-1058

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Rugby Benzoyl Peroxide (NDC 0536-1058). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, do not use this medication if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Rugby Laboratories
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

Active Ingredient

Benzoyl peroxide 10% USP

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do Not Use This Medication If You

  • have very sensitive skin
  • are sensitive to benzoyl peroxide.

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 frequent or in a lower concentration.

Stop Use And Ask A Doctor If

  • irritation becomes severe

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

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.

Other Information

Keep tightly closed at room temperature.

Inactive Ingredients

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

Questions Or Comments?

1-800-645-2158

Principal Display Panel - 29.5 Ml Tube Carton

NDC 0536-1058-75

Rugby®

Acne Medication
Benzoyl Peroxide Lotion USP, 10%

10

1 fl oz (29.5 mL)

Principal Display Panel (29.5 mL Tube Carton)

Principal Display Panel (29.5 mL Tube Carton)

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