Kleer-plex Advanced Acne Care System
FDA Label NDC 37945-876

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio-medical & Pharmaceutical Manufacturing Corporation for the product Kleer-plex Advanced Acne Care System (NDC 37945-876). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding this system contains:, drug facts, active ingredient, purpose, uses, warnings, when using this product, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - 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

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