Paulas Choice Clear Daily Skin Clearing Treatment 2.5% Benzoyl Peroxide Extra Strength

Paulas Choice Clear Daily Skin Clearing Treatment by

Drug Labeling and Warnings

Paulas Choice Clear Daily Skin Clearing Treatment by is a Otc medication manufactured, distributed, or labeled by Paula's Choice, LLC, Thibiant International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Treats acne.
• Helps prevent new acne blemishes.
• Penetrates pores to reduce acne blemishes.

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.

PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76144-611
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-611-01	67 mL in 1 TUBE; Type 0: Not a Combination Product	09/07/2012
2	NDC: 76144-611-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	09/07/2012
3	NDC: 76144-611-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	09/07/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/07/2012

Labeler - Paula's Choice, LLC (029583981)

Registrant - Paula's Choice, LLC (029583981)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(76144-611)

Revised: 1/2022

Document Id: c54e1971-64e2-2d70-e053-2a95a90a6129

34390-5

Set id: 19ae6ea7-cdd4-69f6-e054-00144ff88e88

Version: 4

Effective Time: 20220106