KLEER-PLEX ADVANCED ACNE CARE SYSTEM- salicylic acid 
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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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

Warnings

For external use only.

When using this product

KEEP OUT OF REACH OF CHILDREN

Directions

Acne Treatment Wash

Acne Treatment Gel

Sensitivity Test for a New User - Acne Treatment Gel

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.jpgFront KleerPlexBack.jpgBack

KLEER-PLEX ADVANCED ACNE CARE SYSTEM 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-876
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-876-911 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
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 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
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
TROLAMINE (UNII: 9O3K93S3TK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM SULFATE (UNII: DE08037SAB)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-870-401 in 1 BOX
1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
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 
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWITCH HAZEL (UNII: 101I4J0U34)  
INGRHORSE CHESTNUT (UNII: 3C18L6RJAZ)  
INGRWHITE OAK BARK (UNII: 93LP7Y8EGT)  
INGRECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
INGRCHASTE TREE (UNII: 433OSF3U8A)  
INGRGOLDENSEAL (UNII: ZW3Z11D0JV)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRLEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGR10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
INGRSEBACIC ACID (UNII: 97AN39ICTC)  
INGR1,10-DECANEDIOL (UNII: 5I577UDK52)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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 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
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHEAT GERM OIL (UNII: 14C97E680P)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
BRUCINE SULFATE (UNII: KY7O12XPOQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-874-111 in 1 BOX
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
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 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
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WHEAT GERM OIL (UNII: 14C97E680P)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
BRUCINE SULFATE (UNII: KY7O12XPOQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37945-894-051 in 1 BOX
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
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/FEIBusiness Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-876, 37945-870, 37945-874, 37945-894)

Revised: 11/2014
Document Id: 25c82c9e-09aa-4486-8fa0-a9fb4cd494ba
Set id: 79f8fc90-2447-4224-ac79-1645d1c82d4f
Version: 4
Effective Time: 20141103
 
Bio-Medical & Pharmaceutical Manufacturing Corporation