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  5. Label Information: Replenix Acne Gly-sal 2-2 Foaming Cleanser

FDA Label for Replenix Acne Gly-sal 2-2 Foaming Cleanser

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. INACTIVE INGREDIENTS
    9. PRINCIPAL DISPLAY PANEL - 200 ML BOTTLE LABEL

Replenix Acne Gly-sal 2-2 Foaming Cleanser Product Label

The following document was submitted to the FDA by the labeler of this product Topiderm, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

Sunscreen use is recommended with any glycolic acid product and for an additional week thereafter because some individuals may be more sensitive to sunlight.


Active Ingredient



Salicylic Acid USP, 2%


Purpose



Acne medication


Uses



Skin cleanser for the treatment of acne.


Warnings



For external use only

Keep away from eyes, lips, and mouth. Using other topical medications, while using this product or immediately thereafter, may increase dryness or irritation. If this occurs discontinue use and see your doctor.


Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.


Directions



Wet affected area, apply, and rinse well.

  • Because excessive drying of the skin can occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a physician
  • If bothersome dryness occurs, reduce application to once a day or every other day.

Inactive Ingredients



Water, Sodium Lauroyl Sarcosinate, Sodium Methyl Cocoyl Taurate, PEG-7 Glyceryl Cocoate, Disodium Cocoamphodiacetate, Potassium Hydroxide, Glycolic Acid, Green Tea Extract, Cucumber Extract, Zinc PCA, Copper PCA, Willow Bark Extract, Hydroxyethylcellulose, Phenoxyethanol, Disodium EDTA.


Principal Display Panel - 200 Ml Bottle Label



REPLENiX®
ACNE SOLUTIONS

Gly/Sal® 2-2
Foaming
Cleanser

Glycolic Acid 2%
Salicylic Acid USP, 2%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label - gly sal 01

PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label - gly sal 01


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