PAULAS CHOICE CLEAR DAILY SKIN CLEARING TREATMENT- benzoyl peroxide lotion

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]

ACTIVE INGREDIENT

Benzoyl Peroxide 5%

PURPOSE

Acne Treatment

INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

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.

WARNINGS

For external use only.

DO NOT USE

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

ASK DOCTOR

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

WHEN USING

· 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.

KEEP OUT OF REACH OF CHILDREN

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

STOP USE

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

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)