Rugby Benzoyl Peroxide Gel
FDA Label NDC 50090-1792

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Rugby Benzoyl Peroxide (NDC 50090-1792). 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 if you, when using this product, stop use and consult 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 Drive, Suite 233
Livonia, MI 48152

Active Ingredient

Benzoyl peroxide USP 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only.

Do Not Use If You

  • have very sensitive
  • are sensitive to benzoyl peroxide

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

Otc - Pregnancy Or Breast Feeding

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

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) immediately.

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
  • store at room temperature

Inactive Ingredients

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

Questions Or Comments?

1-800-645-2158

How Supplied

Product: 50090-1792

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

* Please review the disclaimer below.