CLEARASIL RAPID RESCUE SPOT TREATMENT- benzoyl peroxide cream

Clearasil Rapid Rescue Spot Treatment by

Drug Labeling and Warnings

Clearasil Rapid Rescue Spot Treatment by is a Otc medication manufactured, distributed, or labeled by RB Health (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• 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 and dyed fabrics, including carpet and clothing, which may be bleached by 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.
• 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.

Stop use and ask a doctor if irritation becomes severe

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 outer box for full product information
• keep tightly closed
• store at controlled room temperature 68-77 °F (20-25 °C)

Inactive ingredients

Water, Gluconolactone, Glyceryl Stearate, PEG-40 Stearate, Glycerin, PEG-100 Stearate, Cetyl Alcohol, Dimethicone, Magnesium Aluminum Silicate, Xanthan Gum, Benzyl Alcohol, Ammonium Hydroxide, Arginine, Benzoic Acid, Sorbic Acid, Titanium Dioxide

Questions?

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

You may also report side effects to this phone number.

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Distributed by:
RB Health (US),
Parsippany, NJ
07054-0224

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

Clearasil®

RAPID RESCUE
SPOT TREATMENT
CREAM

Benzoyl Peroxide
Acne Medication

VISIBLE
RESULTS
AS FAST AS
4 HOURS

MAXIMUM
STRENGTH

STARTS TO WORK
INSTANTLY

Net wt. 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CLEARASIL RAPID RESCUE SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-433
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Gluconolactone (UNII: WQ29KQ9POT)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-40 Stearate (UNII: ECU18C66Q7)
Glycerin (UNII: PDC6A3C0OX)
PEG-100 Stearate (UNII: YD01N1999R)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Xanthan Gum (UNII: TTV12P4NEE)
Benzyl Alcohol (UNII: LKG8494WBH)
Ammonia (UNII: 5138Q19F1X)
Arginine (UNII: 94ZLA3W45F)
Benzoic Acid (UNII: 8SKN0B0MIM)
Sorbic Acid (UNII: X045WJ989B)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-433-01	1 in 1 CARTON	12/06/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/06/2017

Labeler - RB Health (US) LLC (081049410)