Label: WITCH HAZEL liquid

  • 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 June 20, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Witch Hazel

  • Purpose

    Astringent

  • Indications

    For relief of minor skin Irritations due to

    minor cuts

    minor scraps

    insect bites

  • Warnings

    For external use only

    avoid contact with eyes

    If contact occurs rinse thoroughly with water.

  • When using this product stop using and contact a doctor if

    condition persists or gets worse

    symptoms do not improve within 7 days

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    In case of eye contact flush eyes with running water for 15 minutes.

  • Directions

    Apply liberally to the afflicted area as often as necessary

  • Inactive ingredients

    Alcohol 14% and purified water.

  • Good Neighbor Label

    Principal Display Panel NDC 46122-335-43 Witch Hazel (Hamamelis Water) Distilled Extract Alcohol 14% by volume 16 fl oz (1 pt) 473 mL

  • Sunmark Label

    SM

  • Health Mart Label

    HMWitch.jpjHM

  • INGREDIENTS AND APPEARANCE
    WITCH HAZEL 
    witch hazel liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL855 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9125-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/2016
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884analysis(0395-9125) , manufacture(0395-9125) , pack(0395-9125) , label(0395-9125)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!