CORAL ACTIVES 2 STEP ACNE TREATMENT SYSTEM- benzoyl peroxide gel

Coral Actives by

Drug Labeling and Warnings

Coral Actives by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

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 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 INGREDIENT

Acrylates/C10-C30 Alkyl Acrylate Crosspolymer, Caprylic/Capris Triglyceride, Capryl Glycol, Carbomer, Dimethicone, Dimethyl Isorbide, Disodium EDTA, Ethylhexylglycern, Ethylparaben, Glycerin, Methylparaben, Pentylene Glycol, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, SeaWhip Extract, Sodium Hydroxide, Water

QUESTIONS

Questions? 888-968-0545

Coral Actives 2 Step Acne Treatment

INGREDIENTS AND APPEARANCE

CORAL ACTIVES  2 STEP ACNE TREATMENT SYSTEM
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0187
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	61.62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRICAPRIN (UNII: O1PB8EU98M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0187-3	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/12/2013

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0187) , manufacture(58443-0187) , label(58443-0187)