CLEARASIL ULTRA RAPID ACTION TREATMENT

Main information

  • Trade name:
  • CLEARASIL ULTRA RAPID ACTION TREATMENT- benzoyl peroxide cream
  • Composition:
  • Benzoyl Peroxide 10 g in 100 g
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLEARASIL  ULTRA RAPID ACTION TREATMENT- benzoyl peroxide cream
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Acne Medication for the treatment of acne

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 63824-424-01, 63824-424-02
  • Last update:
  • 31-05-2019

Summary of Product characteristics: dosage, interactions, side effects

CLEARASIL ULTRA RAPID ACTION TREATMENT- benzoyl peroxide cream

Reckitt Benckiser LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Clearas il

Ultra Rapid Action Treatment Cream

Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpos e

Acne Medication

Us e

for the treatment of acne

Warnings

For external use only

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

When using this product

avoid unnecessary sun exposure and use a sunscreen.

avoid contact with the eyes, lips and mouth.

avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this

product.

with other topical acne medications, at the same time or immediately following use of this product,

increased dryness or irritation of the skin may occur. If this occurs, only one medication should be

used unless directed by a doctor.

skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling.

More frequent use or higher concentrations may aggravate skin irritation. Mild irritation may be

reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

cleanse the skin thoroughly before applying medication.

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 use a sunscreen. Allow Clearasil ULTRA Rapid Action Treatment Cream to

®

dry, apply sunscreen after using this product.

If irritation or sensitivity develops, discontinue use of both products and ask a doctor.

Other information

Keep tightly closed

Store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

water, gluconolactone, glyceryl stearate, glycerin, PEG-40 stearate, PEG-100 stearate, cetyl alcohol,

dimethicone, magnesium aluminum silicate, xanthan gum, benzyl alcohol, ammonium hydroxide, arginine,

benzoic acid, sorbic acid, titanium dioxide

Ques tions ?

call 1-866-25-CLEAR (1-866-252-5327).

You may also report side effects to this phone number.

Distributed by:

Reckitt Benckiser LLC

Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearas il

ULTRA

Rapid

Action

Treatment

Cream

Benzoyl Peroxide 10%

Acne Medication

4

HRS

MAXIMUM STRENGTH

Visibly

reduces pimple

size and redness

in as fast as

4 hours

Paraben-free

NET WT.: 1 OZ. (28 g)

®

CLEARASIL ULTRA RAPID ACTION TREATMENT

benzoyl peroxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 38 24-424

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benzo yl Pero xide (UNII: W9 WZN9 A0 GM) (Benzo yl Pero xide - UNII:W9 WZN9 A0 GM)

Benzo yl Pero xide

10 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

wa ter (UNII: 0 59 QF0 KO0 R)

g luco no la cto ne (UNII: WQ29 KQ9 POT)

g lyceryl mo no stea ra te (UNII: 230 OU9 XXE4)

g lycerin (UNII: PDC6 A3C0 OX)

PEG-4 0 stea ra te (UNII: ECU18 C6 6 Q7)

PEG-10 0 stea ra te (UNII: YD0 1N19 9 9 R)

cetyl a lco ho l (UNII: 9 36 JST6 JCN)

dimethico ne (UNII: 9 2RU3N3Y1O)

ma g nesium a luminum silica te (UNII: 6 M3P6 4V0 NC)

xa ntha n g um (UNII: TTV12P4NEE)

benzyl a lco ho l (UNII: LKG8 49 4WBH)

a mmo nia (UNII: 5138 Q19 F1X)

a rg inine (UNII: 9 4ZLA3W45F)

benzo ic a cid (UNII: 8 SKN0 B0 MIM)

so rbic a cid (UNII: X0 45WJ9 8 9 B)

tita nium dio xide (UNII: 15FIX9 V2JP)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 38 24-424-0 1

1 in 1 CARTON

0 6 /15/20 16

1

28 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:6 38 24-424-0 2

1 in 1 CARTON

0 6 /15/20 16

2

12 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Reckitt Benckiser LLC

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 6 /15/20 16

Labeler -

Reckitt Benckiser LLC (094405024)

Revised: 6/2016