BLEMISH- benzoyl peroxide gel

Blemish by

Drug Labeling and Warnings

Blemish by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc., Odan Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient:

Benzoyl Peroxide: 5%

PURPOSE

Purpose: Acne treatment

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

A unique oil-free, color-free benzoyl peroxide gel that helps to gently clear blemishes, blackheads and spots.  Also contains our moisturizing Bio-Maple compound, which helps prevent skin from becoming excessively dry.

Uses

■ Helps treat acne.

■ Dries up acne pimples.

■ Helps prevent new acne pimples.

WARNINGS

Warnings

For external use only.

Do not use on

• broken skin.

• large areas of the body.

When using this product,

• Apply to affected areas only
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with eyes/eye area, lips, mouth and nostrils.  If contact occurs, rinse thoroughly with water.
• This product may bleach hair or dyed fabrics.
• Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin.  Only one drug should be used unless directed by a doctor.
  

Stop use and ask a doctor if too much skin irritation or sensitivity develops or increases.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• Clean the skin thoroughly befor applying.
• Cover the entire affected area with a thin layer 1 to 3 times daily.
• because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2-3 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, use a sunscreen.  Allow medicated acne gel to dry, then follow directions on the sunscreen labeling.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: water, alcohol denat., acer saccharum (maple isolate), disodium PEG-12 dimethicone sulfosuccinate, carbomer, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid

PRINCIPAL DISPLAY PANEL

B. KAMINS

BLEMISH GEL 5%

30mL / 1.7 fl.oz

DIN 02248217

INGREDIENTS AND APPEARANCE

BLEMISH 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-193
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ACER SACCHARUM SAP (UNII: 75UOH57984)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-193-23	30 mL in 1 BOX; Type 0: Not a Combination Product	10/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/01/2010

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Kamins Dermatologics Inc. (254050784)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories Ltd		208585604	manufacture(63550-193) , pack(63550-193)