Enfuselle Acne Clarifying Lotion
FDA Label NDC 59899-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shaklee Corporation for the product Enfuselle Acne Clarifying (NDC 59899-002). 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 drug facts, active ingredient, purpose, uses, warnings, when using this product, keep out of reach of children., directions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts


Active Ingredient

Salicylic Acid (0.5%)

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

  • For external use only.

When Using This Product

  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only  one topical acne medication at a time.
  • Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

In swallowed, get medical help or contact a Poison Control Center right away.

Directions For Use

  • Clean the skin thoroughly before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Water/Eau, SD Alcohol 40-B, Cyclodextrin, Polysorbate 20, Xanthan Gum, 4-Terpineol*, Triethanolamine, Galactoarabinan, Zinc Gluconate, Sodium Coco PG-Dimonium Chloride Phosphate, Leptospermum Scoparium Branch/Leaf Oil, Tocopheryl Acetate, Dipostassium Glycyrrhizate, Panthenol, Disodium EDTA, Cetearyl Ethylhexanoate, Butylene Glycol, Nasturtium Officinale Extract, Arctium Lappa Root Extract, Aloe Barbadensis Leaf Juice, Pyridoxine HCL, Retinyl Palmitate.

Principal Labeling

PARABEN FREE

salicylic acid
acne treatment

1fl. oz. 29mL
120applications

All Skin Types


This exclusive treatment formula gently and comprehensively controls the factors that contribute to the cycle of acne-troubled skin.
Features an exclusive blend of nourishing antioxidants and purifying botanicals to help normalize sebum, unclog pores, speed healing, and reduce
redness caused by acne. With continued use, skin will become visibly smoother, clearer, and shine free.

  • Not tested on animals
  • 100% free of
    occlusive oils

    • Shaklee
    Dist. by/par
    Shaklee Corporation
    4747 Willow Road
    Pleasanton, CA 94588 USA
    Item #39075

    • Breakthrough patented
    formula
    • Contains botanical
    extracts:
    - tea tree (Melaleuca
    alternifolia) oil
    - manuka
    (Leptospermum
    scoparium) oil
    - licorice (Dipotassium
    glycyrrhizate) extract
    - burdock (Arctium
    lappa) root extract
    - watercress (Nasturtium
    officinale) extract
    - aloe vera (Aloe
    barbadensis) leaf juice
    • Features antioxidant
    vitamins A and E
    • Gentle enough to use
    daily for maximum
    acne control
    • 100% fragrance and
    paraben free
    • Allergy tested
    • Clinically formulated
    • Dermatologist tested


    Do not store at
    temperatures above 10O°F.
    U.S. Palent: 6,403,110

    Apply this exclusive facial formula to help keep skin blemish free, speed healing and reduce redness caused by acne. Gentle enough to use daily, this unique blend of botanicals and nourishing antioxidants effectively controls the factors that contribute to the cycle of acnetroubled
    skin.


    WARNINGS: For external use only. Keep out of eyes. “Keep out of reach of children. If excessive dryness or peeling occurs, reduce the application to once a day or every other day.

    Directions: Apply one to three times daily after cleansing and toning. Allow to dry after application. Follow with the Enfuselle treatment or moisturizer for your skin type.

Package Labeling:

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* Please review the disclaimer below.