Label: WITCH HAZEL solution

  • NDC Code(s): 41163-822-43
  • Packager: United Natural Foods, Inc. dba UNFI
  • 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 May 15, 2023

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  • Claims

    • cleans and refreshens skin
    • tones skin
    • soothes sunburn
  • Active ingredient

    Witch hazel 86%

  • Purpose

    Astringent

  • Use

    for relief of minor skin irritations due to:

    • insect bites
    • minor cuts
    • minor scrapes
  • Warnings

    For external use only

  • When using this product

    •avoid contact with the eyes. 

  • Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days

  • Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away.

  • Directions

    apply as often as needed

  • Inactive ingredient

    alcohol 14% by volume

  • Adverse event

    Distriubuted by SUPERVALE INC.

    Eden Praiie, MN 55344 USA

    Contact us at 1-877-932-7948

    or www.supervalu-ourownbrands.com

  • Principal display panel

    NDC 41163-822-43

    EQUALINE

    witch hazel

    astringent

    hamamelis water

    for relief of minor skin irritations due to:

    • insects bites
    • minor cuts
    • minor scrapes

    16 FL OZ (1 PT ) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    WITCH HAZEL 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL860 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-822-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/29/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/29/2009
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(41163-822)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(41163-822)
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