KLEER-PLEX ADVANCED ACNE CARE SYSTEM- salicylic acid kit

Kleer-Plex Advanced Acne Care System by

Drug Labeling and Warnings

Kleer-Plex Advanced Acne Care System by is a Otc medication manufactured, distributed, or labeled by Bio-Medical & Pharmaceutical Manufacturing Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 SystemPrincipal Display PanelNDC# 37945-876-91

KleerPlexFront.jpg KleerPlexBack.jpg

INGREDIENTS AND APPEARANCE

KLEER-PLEX ADVANCED ACNE CARE SYSTEM 
salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37945-876

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-876-91	1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	118 mL
Part 2	1 BOTTLE	236.558 mL
Part 3	1 BOTTLE	30 mL
Part 4	1 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 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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-870-40	1 in 1 BOX
1		118 mL in 1 BOTTLE, PUMP; 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	11/03/2014

Part 2 of 4

KLEER-PLEX PORE PURIFIER AND TONER 
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WITCH HAZEL (UNII: 101I4J0U34)
INGR	HORSE CHESTNUT (UNII: 3C18L6RJAZ)
INGR	WHITE OAK BARK (UNII: 93LP7Y8EGT)
INGR	ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)
INGR	CHASTE TREE (UNII: 433OSF3U8A)
INGR	GOLDENSEAL (UNII: ZW3Z11D0JV)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	LAVENDER OIL (UNII: ZBP1YXW0H8)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	ETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	LEMON OIL, DISTILLED (UNII: ET5GD00TRP)
INGR	PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
INGR	SEBACIC ACID (UNII: 97AN39ICTC)
INGR	1,10-DECANEDIOL (UNII: 5I577UDK52)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		236.558 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Part 3 of 4

KLEER-PLEX PENETRATING ACNE 
salicylic acid gel

Product Information
Item Code (Source)	NDC: 37945-874
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-874-11	1 in 1 BOX
1		30 mL in 1 BOTTLE; 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

Part 4 of 4

KLEER-PLEX TARGETED ACNE PEN 
salicylic acid gel

Product Information
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37945-894-05	1 in 1 BOX
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/03/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Bio-Medical & Pharmaceutical Manufacturing Corporation		072186356	manufacture(37945-876, 37945-870, 37945-874, 37945-894)