Kleer-plex Advanced Acne Care System

Kleer-plex Advanced Acne Care System
SPL v4
SPL
SPL Set ID 79f8fc90-2447-4224-ac79-1645d1c82d4f
Route
TOPICAL
Published
Effective Date 2014-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Water Ammonium Lauryl Sulfate Lauramidopropyl Betaine Propylene Glycol Hydroxypropyl Bis-hydroxyethyldimonium Chloride Trolamine Hypromelloses Magnesium Sulfate Iodopropynyl Butylcarbamate Diazolidinyl Urea Peppermint Oil Methylparaben Propylparaben Alcohol Glycerin Xanthan Gum Polysorbate 20 .alpha.-tocopherol Acetate Wheat Germ Oil Glycolic Acid Tert-butyl Alcohol Brucine Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-11-03

Description

(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

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

(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

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.
Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Warnings

For external use only.

Drug Facts

Acne Treatment Wash and Acne Treatment Gel

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.
Active Ingredient

Salicylic Acid, 2%

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

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

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.
Kleer Plex Advanced Acne System

KleerPlexFront.jpg

 KleerPlexBack.jpg

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.

Structured Label Content

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.
Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Purpose

Acne Treatment

Warnings

For external use only.

Drug Facts (DRUG FACTS)

Acne Treatment Wash and Acne Treatment Gel

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.
Active Ingredient

Salicylic Acid, 2%

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 (Questions or Comments)

281-835-8051

M-F 8 AM to 5 PM

This System Contains: (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

When Using This Product (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.
Kleer Plex Advanced Acne System (Kleer-Plex Advanced Acne System)

KleerPlexFront.jpg

 KleerPlexBack.jpg

Sensitivity Test for A New User Acne Treatment Gel (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.

Advanced Ingredient Data


Raw Label Data

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