CLEAR EXFOLIATING SOLUTION PAULAS CHOICE- salicylic acid cream

Clear Exfoliating Solution by

Drug Labeling and Warnings

Clear Exfoliating Solution by is a Otc medication manufactured, distributed, or labeled by Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredeints                   Purpose

Salicylic Acd 2.0% ................... Acne Treatment

PURPOSE

Uses

• For the treatment of acne
• Penetrates Pores to eliminate most acne blemishes, blackheads, and whiteheads
• Helps prevent new acne blemishes, blackheads and whiteheads

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if skin irritation occurs or gets worse

WARNINGS

Warning

• For external use only
• When using this product 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
  

DOSAGE & ADMINISTRATION

Directions After cleansing with Paula's Choice Clear Pore Normalizing Cleanser

• Cover the entire affected area with a thin layer one to three times daily
• Because excessive drying out of the skin may occur, start with one application daily, then gradually increase to two or three 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 

INACTIVE INGREDIENT

Water (Aqua), Dipropylene Glycol, Pentylene Glycol, Polysorbate 20, Butylene Glycol, Glycerin, Sodium Hyaluronate, Dipotassium Glycrrhizate, Allantoin, Panthenol, PEG/PPG-17/6 Copolymer, Methyl Gluceth-20, Glycereth-26, Bis-PEG-18 Methyl Ether Dimethyl Silane, Sodium Hydroxide, Tetrasodium EDTA, Sodium Metabisulfite 

PRINCIPAL DISPLAY PANEL

PAULA'S CHOICE

CLEAR

ANTI-REDNESS

EXFOLIATING SOLUTION

2% Salicylic Acid

All Skin Types

What it does:

• Clears breakouts
• Unclogs & Minimizes pores
• Fades red marks

118 ml / 4 fl. oz.

INGREDIENTS AND APPEARANCE

CLEAR EXFOLIATING SOLUTION  PAULAS CHOICE
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5002
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)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
GLYCERETH-26 (UNII: NNE56F2N14)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5002-1	118 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2016
2	NDC: 56152-5002-2	15 mL in 1 TUBE; Type 0: Not a Combination Product	08/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/09/2016

Labeler - Cosmetic Enterprises Ltd (017701475)

Registrant - Cosmetic Enterprises Ltd (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(56152-5002)