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  5. Label Information: Hydroseptine

FDA Label for Hydroseptine

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS:
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydroseptine Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma 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.

Active Ingredients



Menthol 0.44%

Zinc Oxide 20.6%


Purpose



Active Ingredients                                        Purpose
Menthol 0.44%...........................External analgesic/anti-itch
Zinc Oxide 20.6%......Skin protectant/anorectal astringent 


Uses



  • A moisture barrier that prevents and heals skin irritations from
  • urine
  • diarrhea
  • prespiration
  • fistula drainage
  • feeding tube site leakage
  • wound drainage (peri-wound skin)
  • minor burns
  • cuts
  • scrapes
  • itching

Warnings



For external use only


When Using This Product



  • not for deep or punctured wounds
  • avoid contact with eyes

Stop Use And Ask Doctor If



  • In case of accidental ingestion contact a physician or Poison Control Center right away
  • if condition worsens or does not improve within 7 days, consult a doctor

Keep Out Of Reach Of Children.




Directions



Cleanse skin gently with mid skin cleanser. Pat dry or allow to air dry. apply a thin layer of Hydroseptine Ointment to reddened or irritated skin 2-4 times daily, or after each incontinent episode or diaper change to promote comfort and long lasting protection.


Inactive Ingredients:



Other information store at room temperature 15-30 C (59-86 F)

Inactive ingredients calamine, chlorothymol, glycerin, lanoline,phenol, sodium bicarbonate, and thymol in a suitable ointment base

Questions or Comments? Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma, Inc.

Fairfield, NJ 07004

www.akronpharma.com

This product is not manufactured or distributed by Calmoseptine Inc., owner of the registered trademark Calmoseptine.


Package Label.Principal Display Panel



100mg - 100mg

100mg - 100mg


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