PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT- benzoyl peroxide lotion 
Paula's Choice, 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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Paulas Choice Clear Daily Skin Clearing Treatment 2.5% Benzoyl Peroxide Extra Strength

Benzoyl Peroxide 5%

Acne Treatment

After cleansing with Paula's Choice CLEAR Pore Normalizing Cleanser and exfoliating with Anti-Redness Exfoliating Solution, cover the affected area with a thin layer 1 to 3 times a day. Because excessive drying of the skin may occur, start with 1 appliation daily and 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. If going outside, use a sunscreen. If sensitivity develops, discontinue use.

For external use only.

Do not use · on broken skin · on large areas of the body · if you are sensitive to benzoyl peroxide.

If too much skin irritation or skin sensitivity develops or increases.

· Avoid unnecessary sun exposure and use a sunscreen · Avoid contact with eyes, lips and mouthIf contact occure, rinse with water · This product may bleach hair or dyed fabrics · Using other topical acne products at the sam etime or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless direct by a doctor.

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

If too much skin irritation or skin sensitivity develops or increases.

Store at 20-26ºC (68-77ºF). · You may report serious adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057.

Water, Propulene Glycol, Bisabolol, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymner, Hydroxyethylcellulose, Sodium Citrate, Laureth-4, Caprylyl Glycol, Hexylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol.

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PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76144-611
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
LEVOMENOL (UNII: 24WE03BX2T)  
ALLANTOIN (UNII: 344S277G0Z)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
LAURETH-4 (UNII: 6HQ855798J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76144-611-0167 mL in 1 TUBE; Type 0: Not a Combination Product09/07/2012
2NDC:76144-611-0215 mL in 1 TUBE; Type 0: Not a Combination Product09/07/2012
3NDC:76144-611-032 mL in 1 PACKET; Type 0: Not a Combination Product09/07/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/07/2012
Labeler - Paula's Choice, LLC (029583981)
Registrant - Paula's Choice, LLC (029583981)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc.083913913manufacture(76144-611)

Revised: 1/2022
Document Id: c54e1971-64e2-2d70-e053-2a95a90a6129
Set id: 19ae6ea7-cdd4-69f6-e054-00144ff88e88
Version: 4
Effective Time: 20220106
 
Paula's Choice, LLC