CLEARASIL ULTRA RAPID ACTION CLEAR SKIN- salicylic acid and benzoyl peroxide kit

Clearasil by

Drug Labeling and Warnings

Clearasil by is a Otc medication manufactured, distributed, or labeled by Reckitt Benckiser LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Rapid Action Daily Face Wash

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

When using this product

• avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water.
• 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.
• limit use to the face and neck

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wet face
• dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area
• cover the entire affected area with a thin layer and rinse thoroughly with warm water 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

Other information

• store in a cool, dry place
• do not freeze

Inactive ingredients

water, sodium cocoyl isethionate, cetearyl alcohol, glycerin, sodium laureth sulfate, sodium cocoamphoacetate, cocamidopropyl betaine, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, disodium EDTA, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract

SPL UNCLASSIFIED SECTION

Rapid Action Pads

Active ingredient

Salicylic acid 2%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Flammable keep away from extreme heat or open flame

When using this product

• avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
• 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.
• limit use to the face and neck

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• clean the skin thoroughly before applying this product
• wipe a pad over face and neck to cover the entire affected area with a thin layer 1 to 3 times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 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

Other information

• keep jar lid tightly closed
• store in a cool, dry place but do not freeze

Inactive ingredients

water, alcohol denat., glycerin, isoceteth-20, sorbitol, sodium hydroxide, fragrance, Lavandula stoechas extract, Helichrysum italicum extract, Cistus monspeliensis extract, disodium EDTA

SPL UNCLASSIFIED SECTION

Rapid Action Vanishing Treatment Cream

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 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 Vanishing Treatment Cream to dry, then follow directions on sunscreen labeling. 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, phenoxyethanol, ammonium hydroxide, isopropylparaben, butylparaben, isobutylparaben, arginine, titanium dioxide

Questions?

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

You may also report side effects to this phone number.

SPL UNCLASSIFIED SECTION

Distributed by: Reckitt Benckiser LLC.
Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - Kit Carton

Clearasil®

ULTRA™

Rapid Action
Clear Skin Kit

MAXIMUM
STRENGTH

Visibly
clearer skin
in as little as
12 hours

• Clearasil Ultra Rapid
  Action Daily Face Wash
  6.78 FL. OZ. (200 mL)
• Clearasil Ultra Rapid
  Action Pads
  90 Pads 3.58 in2 (23.1 cm2)
• Clearasil Ultra Rapid
  Action Treatment Cream
  0.45 OZ. (13 g)

INGREDIENTS AND APPEARANCE

CLEARASIL   ULTRA RAPID ACTION CLEAR SKIN
salicylic acid and benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-423

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-423-00	1 in 1 CARTON

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	200 mL
Part 2	1 JAR	90
Part 3	1 TUBE	13 g

Part 1 of 3

CLEARASIL ULTRA RAPID ACTION  DAILY FACE WASH
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 63824-380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium cocoyl isethionate (UNII: 518XTE8493)
cetostearyl alcohol (UNII: 2DMT128M1S)
glycerin (UNII: PDC6A3C0OX)
sodium laureth-3 sulfate (UNII: BPV390UAP0)
sodium cocoamphoacetate (UNII: W7Q5E87674)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium (UNII: 7FLD91C86K)
lavandula stoechas flowering top (UNII: 70759G2U6A)
helichrysum italicum flower (UNII: P62Y550X24)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-380-88	200 mL 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	09/01/2014

Part 2 of 3

CLEARASIL ULTRA   RAPID ACTION PADS
salicylic acid solution

Product Information
Item Code (Source)	NDC: 63824-345
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	0.03 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
alcohol (UNII: 3K9958V90M)
glycerin (UNII: PDC6A3C0OX)
isoceteth-20 (UNII: O020065R7Z)
sorbitol (UNII: 506T60A25R)
sodium hydroxide (UNII: 55X04QC32I)
lavandula stoechas flowering top (UNII: 70759G2U6A)
Helichrysum italicum flower (UNII: P62Y550X24)
edetate disodium (UNII: 7FLD91C86K)

Product Characteristics
Color		Score
Shape	ROUND (Pad)	Size	231mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-345-01	90 in 1 JAR; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/01/2012

Part 3 of 3

CLEARASIL   ULTRA RAPID ACTION VANISHING TREATMENT
benzoyl peroxide cream

Product Information
Item Code (Source)	NDC: 63824-309
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)
glycerin (UNII: PDC6A3C0OX)
PEG-40 stearate (UNII: ECU18C66Q7)
PEG-100 stearate (UNII: YD01N1999R)
cetostearyl alcohol (UNII: 2DMT128M1S)
dimethicone (UNII: 92RU3N3Y1O)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
xanthan gum (UNII: TTV12P4NEE)
phenoxyethanol (UNII: HIE492ZZ3T)
ammonia (UNII: 5138Q19F1X)
isopropylparaben (UNII: A6EOX47QK0)
butylparaben (UNII: 3QPI1U3FV8)
isobutylparaben (UNII: 0QQJ25X58G)
arginine (UNII: 94ZLA3W45F)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-309-02	13 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	03/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2015

Labeler - Reckitt Benckiser LLC (094405024)