ACNE GEL WASH- salicylic acid gel

Acne Gel Wash by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

treating acne
dries up acne pimples helps prevent new acne pimples

Warnings

Keep out of Reach of Children If swallowed get medical help or contact POISON CONTROL right away

For external use only.
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.

When using this product rinse right away with water if it gets in eyes. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Keep out of reach of children If swallowed get medical help or contact POISON CONTROL right away.

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 over your face or body for approximately 30 seconds. Avoid the delicate eye area. Rinse thoroughly. 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.

Other information

Store at 15-30°C (59-86°F)

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

manufactured and distributed by

Ceela Naturals, LLC

Louisville, KY 40203

Inactive Ingredients

nactive Ingredients: Purified water, isomerized linoleic acid (CLA from Safflower), potassium hydroxide, Aspartate, Oryza sativa extract (Rice Vit E Tocotrienol).

Package Label

INGREDIENTS AND APPEARANCE

ACNE GEL WASH 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42021-031
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)
TOCOTRIENOL (UNII: 0867I0N41V)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42021-031-03	1 in 1 PACKAGE	12/15/2016
1	NDC: 42021-031-02	150 mL in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/18/2016

Labeler - Ceela Naturals (833224822)

Registrant - Ceela Naturals (833224822)

Establishment
Name	Address	ID/FEI	Business Operations
Ceela Naturals		833224822	manufacture(42021-031) , label(42021-031) , repack(42021-031)