KLEER-PLEX TARGETED ACNE PEN- salicylic acid gel 
Bio-Medical & Pharmaceutical Manufacturing Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Box

KLEER-PLEX TARGETED ACNE PEN 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-894
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-894-051 in 1 BOX10/22/201409/01/2021
115 mL in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/22/2014
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-894)

Revised: 12/2022
Document Id: efbd4244-4098-3aa6-e053-2a95a90a774e
Set id: 2cbda9b6-d674-4fd4-b05a-d6727854bd83
Version: 6
Effective Time: 20221213
 
Bio-Medical & Pharmaceutical Manufacturing Corporation