IBLANC RESTORA-BRIGHT ACNE HEALING- benzoyl peroxide cream

iBlanc Restora-Bright by

Drug Labeling and Warnings

iBlanc Restora-Bright by is a Otc medication manufactured, distributed, or labeled by iBlanc Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

USES: FOR THE TREATMENT OF ACNE

ACTIVE INGREDIENT

Active Ingredient:   Benzoyl Peroxide 5.25%

PURPOSE

Uses

• for the treatment of acne

WARNINGS

Warnings

For external use only

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.
  

DO NOT USE

Do not use if you

• have very sensitive skin.
• are sensitive to benzoyl peroxide
  

WHEN USING

When using this product

• avoid unnecessary skin exposure and use a sunscreen
• avoid contact with eyes, lips and mouth.  If eye contact accidentally occurs, rinse eyes throughly with water.
• 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.

INACTIVE INGREDIENT

Inactive Ingredients Aqua (Water), Glycerin, Allantoin, Aloe Barbadensis Leaf Juice Powder, Acrylates/C13-30 Alkyl Acrylate Crosspolymer, Sorbitol, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol

KEEP OUT OF REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

iBlanc Dermaceuticals

RESTORA-BRIGHT
ACNE-HEALING
CREAM

DOSAGE & ADMINISTRATION

APPLY A THIN LAYER TO BLEMISHES DAILY AFTER CLEANSING SKIN. IF NEEDED AND NO DRYNESS OR PEELING OCCURS, USE FOR TOUCH-UP THROUGHOUT THE DAY.

INGREDIENTS AND APPEARANCE

IBLANC RESTORA-BRIGHT  ACNE HEALING
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52960-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	5.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Allantoin (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Carbomer Copolymer TYPE A (UNII: 71DD5V995L)
Sorbitol (UNII: 506T60A25R)
Sodium Hydroxide (UNII: 55X04QC32I)
Caprylyl Glycol (UNII: 00YIU5438U)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52960-101-12	45 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/01/2012

Labeler - iBlanc Inc. (078510606)

Registrant - iBlanc Inc. (078510606)