Clearasil® PerfectaWash™ Ultra Rapid Action Face Wash Dispenser and Refills

Drug Labeling and Warnings

Drug Details [pdf]

CLEARASIL PERFECTAWASH ULTRA RAPID ACTION FACE WASH DISPENSER AND REFILLS- salicylic acid 
RB Health (US) 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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Clearasil® PerfectaWash™
Ultra Rapid Action Face Wash Dispenser and Refills

Drug Facts - Soothing Plant Extracts

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

Stop use and ask a doctor if skin or eye irritation develops

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

Directions

• wet face
• wet hands and place under dispenser nozzle to automatically dispense one dose of face wash. Massage gently onto face and neck, avoiding the delicate eye area.
• rinse thoroughly with warm water and pat dry
• for best results, use twice daily

Other information

• store in a cool, dry place
• do not store in direct sunlight

Inactive ingredients

water, glycerin, sodium laureth sulfate, cocamidopropyl betaine, coco-glucoside, glycol distearate, sodium chloride, laureth-4, tocopheryl acetate, polyquaternium-43, fragrance, propylene glycol, formic acid, phenoxyethanol, methylparaben, butylparaben, ethylparaben, isobutylparaben, propylparaben, lavandula stoechas extract, helichrysum italicum extract, cistus monspeliensis extract, FD&C blue no. 1, FD&C yellow no. 6, FD&C yellow no. 5

Drug Facts - Superfruit Splash

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

Stop use and ask a doctor if skin or eye irritation develops

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

Directions

• wet face
• wet hands and place under dispenser nozzle to automatically dispense one dose of face wash. Massage gently onto face and neck, avoiding the delicate eye area.
• rinse thoroughly with warm water and pat dry
• for best results, use twice daily

Other information

• store in a cool, dry place
• do not store in direct sunlight

Inactive ingredients

water, glycerin, sodium laureth sulfate, cocamidopropyl betaine, coco-glucoside, sodium chloride, laureth-4, fragrance, tocopheryl acetate, propylene glycol, polyquaternium-43, disodium EDTA, trideceth-9, rubus idaeus (raspberry) juice, vaccinium macrocarpon (cranberry) fruit extract, phenoxyethanol, bisabolol, citric acid, methylparaben, butylparaben, ethylparaben, isobutylparaben, propylparaben, D&C red no. 33, FD&C yellow no. 6

Questions?

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 - Kit Carton

Clearasil®

150 DAY
SUPPLY**

U L T R A

Rapid Action Face Wash

Salicylic Acid 2% Acne Medication

Includes 3 refills

1 x Superfruit Splash
+
2 x Soothing Plant Extracts

PerfectaWash™

Automatic Face Wash
Dispenser & Refills

Perfect dose* for visibly clearer
skin without overdrying

Total 15 FL OZ (450 mL), Each 5 FL OZ (150 mL)
Dispenser, 3 Refills (100 doses each), 3 x AA

*1 dose = 1 activation of dispenser
**Based upon 1 dose used twice daily

CLEARASIL PERFECTAWASH  ULTRA RAPID ACTION FACE WASH DISPENSER AND REFILLS
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63824-411

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-411-00	1 in 1 CARTON	05/01/2012	09/02/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	150 mL
Part 2	2 BOTTLE	300 mL

Part 1 of 2

CLEARASIL PERFECTAWASH   ULTRA RAPID ACTION FACE WASH REFILL - SUPERFRUIT SPLASH
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 63824-360
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)
glycerin (UNII: PDC6A3C0OX)
sodium laureth-3 sulfate (UNII: BPV390UAP0)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
coco glucoside (UNII: ICS790225B)
sodium chloride (UNII: 451W47IQ8X)
laureth-4 (UNII: 6HQ855798J)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
propylene glycol (UNII: 6DC9Q167V3)
edetate disodium (UNII: 7FLD91C86K)
trideceth-9 (UNII: X9HD79I514)
raspberry juice (UNII: 427AYI9PDE)
cranberry (UNII: 0MVO31Q3QS)
phenoxyethanol (UNII: HIE492ZZ3T)
levomenol (UNII: 24WE03BX2T)
citric acid monohydrate (UNII: 2968PHW8QP)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
D&C red no. 33 (UNII: 9DBA0SBB0L)
FD&C yellow no. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-360-05	150 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2012	09/02/2019

Part 2 of 2

CLEARASIL PERFECTAWASH   ULTRA RAPID ACTION FACE WASH REFILL - SOOTHING PLANT EXTRACTS
salicylic acid lotion

Product Information
Item Code (Source)	NDC: 63824-361
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)
glycerin (UNII: PDC6A3C0OX)
sodium laureth-3 sulfate (UNII: BPV390UAP0)
cocamidopropyl betaine (UNII: 5OCF3O11KX)
coco glucoside (UNII: ICS790225B)
glycol distearate (UNII: 13W7MDN21W)
sodium chloride (UNII: 451W47IQ8X)
laureth-4 (UNII: 6HQ855798J)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
propylene glycol (UNII: 6DC9Q167V3)
formic acid (UNII: 0YIW783RG1)
phenoxyethanol (UNII: HIE492ZZ3T)
methylparaben (UNII: A2I8C7HI9T)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C yellow no. 6 (UNII: H77VEI93A8)
FD&C yellow no. 5 (UNII: I753WB2F1M)
lavandula stoechas flowering top (UNII: 70759G2U6A)
helichrysum italicum flower oil (UNII: O97ZV7726K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63824-361-05	150 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2012	09/02/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	05/01/2012	09/02/2019

Labeler - RB Health (US) LLC (081049410)

Revised: 9/2019

Document Id: e75a08f8-5355-476a-b609-bb154ff77863

34390-5

Set id: 3e84f3ae-6fe2-44a3-a5ee-1dbaaa03b8ee

Version: 2

Effective Time: 20190913