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  5. Label Information: Gly-sal 5-2 Pads

FDA Label for Gly-sal 5-2 Pads

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. PRINCIPAL DISPLAY PANEL - 60 PAD JAR LABEL

Gly-sal 5-2 Pads 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

  • Using other topical acne medication at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • Flammable; keep tightly closed, away from flame and heat.
    • 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



Cleansing pads for the treatment of acne, with the skin enhancement properties of Glycolic acid.


Warnings



  • For external use only.
  • Keep away from eyes, lips, and mouth.

Otc - Stop Use



  • If irritation develops, discontinue use and consult a doctor.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.

Directions



  • Wipe the entire affected area with a moist pad one to three times daily.
  • 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 or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients



Purified Water, SD Alcohol 40B (13% v/v), Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate-20, Sodium Benzoate, Imidazolidinyl Urea, Ammonium Hydroxide, Acetone, Disodium EDTA.


Principal Display Panel - 60 Pad Jar Label



REPLENiX®
ACNE SOLUTIONS

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

Gly/Sal® 5-2
Pads

Glycolic Acid 5%
Salicylic Acid USP, 2%

60 Pads

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label - replenix 01

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Label - replenix 01


* Please review the disclaimer below.