Label: PREPARATION H SOOTHING RELIEF COOLING- witch hazel aerosol, spray

  • NDC Code(s): 0573-2889-01
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 April 8, 2021

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  • Active ingredients

    Witch hazel 20%

  • Purpose

    Astringent

  • Uses

    ▪
    helps relieve the local itching and discomfort associated with hemorrhoids
    ▪
    temporary relief of irritation and burning
    ▪
    aids in protecting irritated anorectal areas
  • Warnings

    For external use only

    When using this product

    ▪
    do not exceed the recommended daily dosage unless directed by a doctor
    ▪
    do not put this product into the rectum by using fingers or any mechanical device or applicator
    ▪
    Warning – avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
    ▪
    Warning – use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    Stop use and ask a doctor if

    ▪
    bleeding occurs
    ▪
    condition worsens or does not improve within 7 days

    Keep out of reach of children.

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

  • Directions

    ▪
    Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying the spray.
    ▪
    apply externally to the affected area up to 6 times daily or after each bowel movement
    ▪
    children under 12 years of age: consult a doctor
    ▪
    shake well before using
    ▪
    hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • Other information

    ▪
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions?

    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

  • Additional information

    No Touch Spray

    Do not use if sleeve band around cap is broken or missing

    Dist. By: GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks owned or licensed by GSK

    ©2021 GSK or licensor

    PAA172637 (Front Carton)

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2889-01

    PREPARATION H

    NEW!

    soothing
    RELIEF
    cooling spray

    HEMORRHOIDAL SPRAY

    with ALOE

    Quickly Soothes and Cools Discomfort

    Relieves Itching, Burning and Irritation

    Gentle for Daily Use

    NET WT 2.7 OZ (77 g)

    Prep H Soothing Relief Cooling Spray 2.7oz (77 g)
  • INGREDIENTS AND APPEARANCE
    PREPARATION H  SOOTHING RELIEF COOLING
    witch hazel aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2889
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2889-0177 g in 1 CANISTER; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/12/2021
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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