Label: ICHTHAMMOL 20%- ichthammol ointment

  • NDC Code(s): 69396-004-20
  • Packager: TRIFECTA PHARMACEUTICALS USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated September 19, 2023

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  • Drug Facts

  • Active ingredient

    Ichthammol 20%

  • Purpose

    Drawing Salve

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Suggested Use

    • Treating insect bites and stings from mosquitoes, spider, and bees • Removing splinters and silvers • Treating plant irritations, such as nettles or poison ivy • Treating minor skin infections such as an ingrown toenail • Soothing skin relief • Apply to minor skin irritations

  • Warnings

    • For external use only • Do not use in eyes • Ask a doctor before use if you have deep puncture wounds or serious burns • Stop use and ask doctor if redness, irritation, swelling or pain persists

    If swallowed, get medical help or contact a Poison Control Center immediately.

    Before using any medication, read all label directions.

    Keep this carton, it contains important information.

  • Directions

    Cleanse affected area. Apply on gauze bandage once or twice a day. Repeat as necessary. Do not rub or massage affected area.

  • Inactive Ingredients

    Lanolin, Petrolatum

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Trifecta Pharmaceuticals USA TM

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL 33301 USA

    1-888-296-9067

  • Packaging

    4015 GLOBE ICHTHAMMOL OINTMENT 20 PERCENT 1OZ REV06 052223 CDER

  • INGREDIENTS AND APPEARANCE
    ICHTHAMMOL 20% 
    ichthammol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ICHTHAMMOL (UNII: NQ14646378) (ICHTHAMMOL - UNII:NQ14646378) ICHTHAMMOL20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-004-201 in 1 BOX05/25/2016
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/12/2015
    Labeler - TRIFECTA PHARMACEUTICALS USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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