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  5. Label Information: Replenix Acne Solutions Wash

FDA Label for Replenix Acne Solutions Wash

View Indications, Usage & Precautions

Table of Contents

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

Replenix Acne Solutions Wash 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


Active Ingredients



Benzoyl Peroxide USP, 10%


Purpose



Acne treatment


Uses



BP Wash is a therapeutic combination of sudsing cleanser and benzoyl peroxide for the treatment of acne.


Otc - When Using



  • When using this product avoid unnecessary sun exposure and use a sunscreen.
  • For external use only.
  • Keep away from eyes, lips, and mouth.
  • If irritation or sensitivity develops, discontinue use and consult a doctor.
  • Using other topical acne medications 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.
  • May bleach fabrics.

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



  • Shake well. Wet affected area, wash, and rinse well.
  • Use once or twice daily or as directed by a physician.
  • If bothersome drying or peeling occurs, reduce applications.
  • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Inactive Ingredients



Carbomer, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP.


Principal Display Panel - 200 Ml Tube Label



REPLENiX®
ACNE SOLUTIONS

Acne Wash

Benzoyl Peroxide USP, 10%

Net 6.7 fl. oz. (200 ml)

Topix Pharmaceuticals, Inc.
N. Amityville, NY 11701

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label - replenix 01

PRINCIPAL DISPLAY PANEL - 200 ml Tube Label - replenix 01


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