CORAL ACTIVES PENETRATING ACNE SERUM   - benzoyl peroxide gel 
Oraceutical LLC

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Drug Facts

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

Questions?

1-877-523-7647

CORAL ACTIVES PENETRATING ACNE SERUM   benzoyl peroxide   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 67303-001-02 1 BOTTLE In 1 CARTON contains a BOTTLE, PUMP (67303-001-01) 1 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

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: 08/2010Oraceutical LLC