Label: HYDROSEPTINE- zinc oxide, menthol ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 10, 2023

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  • 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.

  • PRINCIPAL DISPLAY PANEL

    100mg

  • INGREDIENTS AND APPEARANCE
    HYDROSEPTINE 
    zinc oxide, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-6743
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.44 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CHLOROTHYMOL (UNII: LJ25TI0CVT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PHENOL (UNII: 339NCG44TV)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    THYMOL (UNII: 3J50XA376E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-6743-1100 g in 1 JAR; Type 0: Not a Combination Product11/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/05/2021
    Labeler - AKRON PHARMA INC (067878881)
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