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  5. Label Information: Rugby Benzoyl Peroxide Wash Acne Medication

FDA Label for Rugby Benzoyl Peroxide Wash Acne Medication

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE IF YOU
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND CONSULT A DOCTOR IF
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 237 G BOTTLE LABEL

Rugby Benzoyl Peroxide Wash Acne Medication Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Distributed by:
RUGBY® LABORATORIES
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



  • shake well
  • Wet area to be cleansed
  • Sensitive Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below
  • one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry
  • 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, cetyl alcohol, disodium EDTA, disodium laureth sulfosuccinate, glycerin, glyceryl stearate, laureth-7, magnesium aluminum silicate, PEG-100 stearate, propylene glycol, sodium coco-sulfate, sodium lauroamphoacetate, water, xanthan gum.


Questions Or Comments?



1-800-645-2158


Principal Display Panel - 237 G Bottle Label



Rugby®

NDC 0536-1351-42

Benzoyl Peroxide
Topical Wash USP

10%

Acne Medication

* Please review the disclaimer below.