KLEER-PLEX TARGETED ACNE PEN- salicylic acid gel

KLEER-PLEX TARGETED ACNE PEN by

Drug Labeling and Warnings

KLEER-PLEX TARGETED ACNE PEN by is a Otc medication manufactured, distributed, or labeled by Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Acne Treatment Gel

Active Ingredients

Salicylic Acid, 2%

Purpose

Acne Treatment

Use

For the management of acne.
Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal.
Penetrates pores to eliminate most acne blemishes.
Helps prevent new acne pimples.

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.

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Directions

Each night, dispense a small amount of gel onto the fingertips.
Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.
Repeat after perspiration or makeup use.
If dryness occurs, reduce frequency to once each day.

Sensitivity test for a new user

Apply product sparingly to one or two small affected areas during the first 3 days.
If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.

Questions or comments

281-835-8051

M-F 8 AM to 5 PM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KLEER-PLEX TARGETED ACNE PEN 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37945-894
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  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BRUCINE SULFATE (UNII: KY7O12XPOQ)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
PEPPERMINT OIL (UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHEAT GERM OIL (UNII: 14C97E680P)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-894-05	1 in 1 BOX	10/22/2014
1		15 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/22/2014

Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(37945-894)