CLEAR ACNE BODY PAULAS CHOICE- salicylic acid spray

Clear Acne Body by

Drug Labeling and Warnings

Clear Acne Body 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 Ingredients             Purpose

Salicylic Acid 2.0%            Acne Treatment        

PURPOSE

Uses

For the treatment of of Acne

Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads

KEEP OUT OF REACH OF CHILDREN

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

 

INDICATIONS & USAGE

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

WARNINGS

Warnings

For external use only.

Do not use

on broken skin

on large areas of the body

When using this product skin irritation and dryness is mroe likely to occur if you use another topical acne medication at the same time. If irritation, only use one topical acne medication at a time

DOSAGE & ADMINISTRATION

Directions

After cleansing with Paula's Choice Clear Pore Normalizing Cleanser and exfoliating with Paula's Choice Clear Anti-Redness Exfoliating Solution.

Cover the entire affected area with a thin layer one to three times daily.

Hold container 4 to 6 inches from the skin to apply.

Do not spray directly into face. Spray on hands, then apply to face.

Because excessive drying 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

 Inactive ingredients Water (Aqua), Dipropylene Glycol, Butylene Glycol, Polysorbate 20, Pentylene Glycol, Panthenol, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Glycyrrhiza Glabra (Licorice) Root Extract, Berberis Vulgaris (Barberry) Root Extract, Lauric Acid, Allantoin, Glycerin, PEG/PPG-17/6 Copolymer, Methyl Gluceth-20, Glycereth-26, Sodium Hydroxide, Sodium Metabisulfite, Disodium EDTA, Potassium Sorbate

PRINCIPAL DISPLAY PANEL

 Paula's Choice

Clear Acne Body Spray

118ml/ 4 fl oz

INGREDIENTS AND APPEARANCE

CLEAR ACNE BODY  PAULAS CHOICE
salicylic acid spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5000
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 118 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PANTHENOL (UNII: WV9CM0O67Z)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
BERBERIS VULGARIS ROOT (UNII: ITJ40JX79U)
LAURIC ACID (UNII: 1160N9NU9U)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
GLYCERETH-26 (UNII: NNE56F2N14)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5000-1	118 mL in 1 BOTTLE, SPRAY; 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(56152-5000)