CORAL ACTIVES PENETRATING ACNE SERUM - benzoyl peroxide gel
Oraceutical LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Benzoyl Peroxide 6%

Purpose

Acne Medication

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

have very sensitive skin
are sensitive to benzoyl peroxide

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
avoid unnecessary sun exposure and use a sunscreen
avoid contact with the eyes, lips, and mouth
avoid contact with hair and dyed fabrics, which may be bleached by this product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to three times daily
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
if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Caprylic/Capric Triglyceride (and) Sea Whip Extract, Caprylyl Glycol (and) Ethylhexylglycerin, Dimethicone, Dimethyl Isosorbide, Disodium EDTA, Glycerin, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Sodium Hydroxide, Water

Coral Actives Penetrating Acne Serum with 6% Benzoyl Peroxide and Sea Whip Extract 1 fl.oz. / 30 ml image of carton

Questions?

1-877-523-7647

CORAL ACTIVES PENETRATING ACNE SERUM
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67303-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
benzoyl peroxide (benzoyl peroxide)	benzoyl peroxide	60 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
CARBOMER COPOLYMER TYPE A
MEDIUM-CHAIN TRIGLYCERIDES
PSEUDOPTEROGORGIA ELISABETHAE
CAPRYLYL GLYCOL
Ethylhexylglycerin
Dimethicone
Dimethyl Isosorbide
EDETATE DISODIUM
Glycerin
PENTYLENE GLYCOL
Phenoxyethanol
Phenyl Trimethicone
SODIUM HYDROXIDE
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:67303-001-02	1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON	contains a BOTTLE, PUMP (67303-001-01)
1	NDC:67303-001-01	30 mL in 1 BOTTLE, PUMP	This package is contained within the CARTON (67303-001-02)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333D	08/23/2010	09/30/2011

Labeler - Oraceutical LLC (005693770)

Establishment
Name	Address	ID/FEI	Operations
Oraceutical LLC		005693770	analysis, label, manufacture, pack

Establishment
Name	Address	ID/FEI	Operations
Consumer Product Testing Company		040754764	analysis

Revised: 01/2012 Oraceutical LLC