Paula's Choice CLEAR Daily Skin Clearing Treatment 2.5% Benzoyl Peroxide, Regular 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. 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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Paula's Choice CLEAR Daily Skin Clearing Treatment 2.5% Benzoyl Peroxide, Regular Strength

Benzoyl Peroxide 2.5%

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 application 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 suncreen. If sensititivy 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 expossure and use a sunscreen. ·Avoid contact with eyes, lips, and mouth. ·This product may bleach hair or dyed fabrics. ·Using other topical acne products at the same time or right after use of thsi product may increase dryness or irritation of the skin. If this occurs, only one drug should be used unless directed 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 20-26°C (68-77°F). You may report serious adverse reactions to 1030 SW 34th Street, Suite A, Renton, WA 98057.

Water, Propylane Glycol, Bisabolol, Allantoin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 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: 76144-610
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LEVOMENOL (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)
LAURETH-4 (UNII: 6HQ855798J)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76144-610-01	67 mL in 1 TUBE; Type 0: Not a Combination Product	01/25/2021
2	NDC: 76144-610-02	15 mL in 1 TUBE; Type 0: Not a Combination Product	01/25/2021
3	NDC: 76144-610-03	2 mL in 1 PACKET; Type 0: Not a Combination Product	01/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	09/04/2012

Labeler - Paula's Choice, LLC (029583981)

Revised: 1/2022

Document Id: c54e27bc-f38a-af30-e053-2995a90a6c0a

34390-5

Set id: 19ad8ddf-b4ae-582a-e054-00144ff88e88

Version: 4

Effective Time: 20220106