ANTI-BLEMISH- salicylic acid disc

Anti-Blemish by

Drug Labeling and Warnings

Anti-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:

Salicylic acid 2%

PURPOSE

Purpose:

Acne treatment

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

INDICATIONS & USAGE

A sophisticated anti-blemish pad formulated with pharmaceutical grade, proven acne-fighting ingredients to help clear blemishes and blackheads as well as prevent future breakouts. This hydrating, innovative and gentle formula will improve skin texture and clarity, as well as moisturize to help prevent skin from over-drying or becoming flaky. Ideal for both adolescent and adult acne.

Uses

■ helps dissolve excess oil (sebum)

■ helps reduce bacteria that may cause breakouts

■ helps penetrate pores to control acne blemishes

■ helps prevent new blemishes

WARNINGS

Warnings

For external use only.

Avoid contact with eyes when using this product. If contact occurs, rinse abundantly with water to remove.

Discontinue use in case of excessive skin irritation or if condition does not improve. If irritation persists, consult a health care practitioner.

Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a health care practitioner.

Keep out of children’s reach. Do not use if security seal is missing or broken. Close tightly after use. Keep product in original jar.

Other information

Store at room temperature 15-30°C (59-86°F).

DOSAGE & ADMINISTRATION

Directions
■ Use the pad to wipe the entire affected area after cleansing and toning face. Do not leave pad on skin for an extended period of time.
■ Begin with one application daily, gradually increasing up to two to three times daily or as directed by a health care practitioner.
■ Application should be reduced if severe dryness occurs. When using this product, it is always recommended to apply a sunscreen before sun exposure.

INACTIVE INGREDIENT

Inactive ingredients:

water, octoxynol-9, acer saccharum (maple isolate), octoxynol-12, sodium thiosulfate, sodium hydroxide, zinc sulfate, mentha piperita (peppermint) oil, benzyl alcohol.

PRINCIPAL DISPLAY PANEL

B. KAMINS
Anti-Blemish Pads with salicylic acid
35 applications
NPN 80014870

INGREDIENTS AND APPEARANCE

ANTI-BLEMISH 
salicylic acid disc

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-154
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
MAPLE SYRUP (UNII: 75UOH57984)
SODIUM THIOSULFATE (UNII: HX1032V43M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ZINC SULFATE (UNII: 89DS0H96TB)
PEPPERMINT OIL (UNII: AV092KU4JH)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-154-90	35 in 1 BOX; Type 0: Not a Combination Product	08/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/01/2010

Labeler - Kamins Dermatologics Inc. (254050784)