Rugby®

Rugby®
SPL v5
SPL
SPL Set ID d0cb59bc-3c35-4861-bdff-87b27a0e1d13
Route
TOPICAL
Published
Effective Date 2024-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (100 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Cetyl Alcohol Edetate Disodium Disodium Laureth Sulfosuccinate Glycerin Glyceryl Monostearate Laureth-7 Magnesium Aluminum Silicate Peg-100 Stearate Propylene Glycol Sodium Coco-sulfate Sodium Lauroamphoacetate Water Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-03-07 Until 2026-08-01

Description

Drug Facts

Purpose

Acne medication


Medication Information

Purpose

Acne medication

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
  • 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.
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, 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

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
Principal Display Panel 237 G Bottle Label

Rugby®

NDC 0536-1351-42

Benzoyl Peroxide

Topical Wash USP

10%

Acne Medication

  • Helps to keep skin clear
  • Helps dry oily skin
  • Helps clear acne pimples

NET WT 8.5 OZ (237g)


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
  • 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.
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, 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? (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
Principal Display Panel 237 G Bottle Label (PRINCIPAL DISPLAY PANEL - 237 g Bottle Label)

Rugby®

NDC 0536-1351-42

Benzoyl Peroxide

Topical Wash USP

10%

Acne Medication

  • Helps to keep skin clear
  • Helps dry oily skin
  • Helps clear acne pimples

NET WT 8.5 OZ (237g)


Advanced Ingredient Data


Raw Label Data

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