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Kleer-Plex Advanced Acne Care System

Dosage form: kit
Ingredients: SALICYLIC ACID 20mg in 1mL;
Labeler: Bio-Medical & Pharmaceutical Manufacturing Corporation
NDC Code: 37945-876

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.

Kleer-Plex Advanced Acne Care System

THIS SYSTEM CONTAINS:

(1) Foaming Acne Clarifier

       NDC 37945-870-40

(1) Pore Purifier & Toner

(1) Penetrating Acne Gel

       NDC 37945-874-11

(1) Targeted Acne Pen

       NDC 37945-894-05

DRUG FACTS

Acne Treatment Wash and Acne Treatment Gel

Active Ingredient

Salicylic Acid, 2%

Purpose

Acne Treatment

Uses
  • 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

Directions

Acne Treatment Wash

  • At least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.
  • Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.
  • Repeat after perspiration or makeup use.
  • If dryness occurs, reduce frequency to once each day.

Acne Treatment Gel

  • 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 - Acne Treatment Gel
  • 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

Acne Treatment Wash

Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Propylene Glycol, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Triethanolamine, Hydroxypropylmethylcellulose, Magnesium Sulfate, 3-iodo-2-propynylbutylcarbamate, Diazolidinyl Urea, Peppermint Oil, Methylparaben, Propylparaben.

Acne Treatment Gel

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

Kleer-Plex Advanced Acne System
Principal Display Panel
NDC# 37945-876-91

KleerPlexFront.jpg KleerPlexBack.jpg

Established Pharmacological Class
SubstancePharmacological Class
Kleer-Plex Pore Purifier and TonerFace and Neck (excluding shaving preparations)
KLEER-PLEX ADVANCED ACNE CARE SYSTEM 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-876
Packaging
#Item CodePackage Description
1NDC:37945-876-911 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 118 mL
Part 21 BOTTLE 236.558 mL
Part 31 BOTTLE 30 mL
Part 41 APPLICATOR 15 mL
Part 1 of 4
KLEER-PLEX FOAMING ACNE CLARIFIER 
salicylic acid liquid
Product Information
Item Code (Source)NDC:37945-870
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AMMONIUM LAURYL SULFATE 
LAURAMIDOPROPYL BETAINE 
PROPYLENE GLYCOL 
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE 
TROLAMINE 
HYPROMELLOSES 
MAGNESIUM SULFATE 
IODOPROPYNYL BUTYLCARBAMATE 
DIAZOLIDINYL UREA 
PEPPERMINT OIL 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:37945-870-401 BOTTLE, PUMP in 1 BOX
1118 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/03/2014
Part 2 of 4
KLEER-PLEX PORE PURIFIER AND TONER 
Product Information
Ingredients
Ingredient NameQuantity
WITCH HAZEL 
HORSE CHESTNUT 
WHITE OAK BARK 
ECHINACEA, UNSPECIFIED 
CHASTE TREE 
GOLDENSEAL 
ALCOHOL 
LAVENDER OIL 
POLYSORBATE 20 
ETHYL LAUROYL ARGINATE HYDROCHLORIDE 
GLYCERIN 
LEMON OIL, DISTILLED 
PHENYLETHYL ALCOHOL 
BUTYLENE GLYCOL 
10-HYDROXYDECANOIC ACID 
SEBACIC ACID 
1,10-DECANEDIOL 
Packaging
#Item CodePackage Description
1236.558 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 4
KLEER-PLEX PENETRATING ACNE 
salicylic acid gel
Product Information
Item Code (Source)NDC:37945-874
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
XANTHAN GUM 
POLYSORBATE 20 
PEPPERMINT OIL 
.ALPHA.-TOCOPHEROL ACETATE 
WHEAT GERM OIL 
GLYCOLIC ACID 
TERT-BUTYL ALCOHOL 
BRUCINE SULFATE 
Packaging
#Item CodePackage Description
1NDC:37945-874-111 BOTTLE in 1 BOX
130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/22/2014
Part 4 of 4
KLEER-PLEX TARGETED ACNE PEN 
salicylic acid gel
Product Information
Item Code (Source)NDC:37945-894
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
GLYCERIN 
XANTHAN GUM 
POLYSORBATE 20 
PEPPERMINT OIL 
.ALPHA.-TOCOPHEROL ACETATE 
WHEAT GERM OIL 
GLYCOLIC ACID 
TERT-BUTYL ALCOHOL 
BRUCINE SULFATE 
Packaging
#Item CodePackage Description
1NDC:37945-894-051 APPLICATOR in 1 BOX
115 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/22/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/03/2014
Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
Establishment
NameAddressID/FEIOperations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-876, 37945-870, 37945-874, 37945-894)

 
Bio-Medical & Pharmaceutical Manufacturing Corporation

Medically reviewed on Nov 5, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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