CLEAN ACNE- salicylic acid gel

Clean Acne by

Drug Labeling and Warnings

Clean Acne by is a Otc medication manufactured, distributed, or labeled by Ceela Naturals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                     Purpose

Salicylic Acid 2% ............Acne Treatment

PURPOSE

Ceela

Naturals Skin Care

ACNE Body Wash

Salicylic Acid

Medicated Cleanser

• treating body acne
  
• dries up acne pimples
• helps prevent new body acne

Sensitivity Test for New User

Apply product sparingly on two small affected areas during first 3 days. If no discomfort occurs, follow below stated directions.

KEEP OUT OF REACH OF CHILDREN

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

Indications & Usage

Treats acne

Directions

​Squeeze a small amount into the palm of your hand and create a slight lather using cool or warm water. Gently massage the lather into your face or body for 30 seconds. Avoid delicate eye area. Rinse thoroughly. Because excessive drying 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 the application to once aday or every other day. 

WARNINGS

Warning: for external use only.

Using other topical acne medications at the same time or immediately following use of this product  may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

When using this product avoid contact with eyes.  If contact occurs, flush thoroughly with water.

Stop or ask a doctor if condition worsens or does not improve with regular use. If skin irritation develops or sensitivity develops or increases.

Other information

Keep carton for full drug facts Store at 15-30°C (59-86°F)

Questions? Call: 800 624 4532 or visit our website at ceelaskincare.com

manufactured and distributed by

Ceela Naturals, LLC

Louisville, KY 40204

INACTIVE INGREDIENT

Inactive Ingredients: water, isomerized linoleic acid (CLA from Safflower), potassium hydroxide, Aspartate, Oryza sativa extract (Rice Bran: Vit E Tocotrienol,  Calendula officinalis (Natural) extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLEAN ACNE 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42021-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOMERIZED SAFFLOWER ACID (UNII: 70S2158RCI)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ASPARTIC ACID (UNII: 30KYC7MIAI)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42021-030-01	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/07/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	12/07/2014

Labeler - Ceela Naturals (833224822)

Registrant - Ceela Naturals (833224822)

Establishment
Name	Address	ID/FEI	Business Operations
Ceela Naturals		833224822	manufacture(42021-030)