Label: SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL- hemorrhoidal wipes with witch hazel cloth

  • NDC Code(s): 21130-800-48
  • Packager: Better Living Brands 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 August 28, 2020

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

  • ACTIVE INGREDIENT

    Witch hazel 50%

  • 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

  • STOP USE AND ASK A DOCTOR IF

    bleeding occurs

    condition worsens or does not improve within 7 days

  • DIRECTIONS

    adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area

    use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard

    children under 12 years of age: consult a doctor

  • OTHER INFORMATION

    store at room temperature

  • INACTIVE INGREDIENTS

    2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium Cocoamphodiacetate, Glycerin, Iodopropynyl Butylcarbamate, PEG-75 Lanolin, Propylene Glycol, Sodium Citrate, Water

  • Other Uses

    for vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.

    for use as a moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

  • FOR COMMENTS OR QUESTIONS PLEASE

    DISTRIBUTED BY BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

  • Keep out of reach of children

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

  • PRINCIPAL DISPLAY PANEL - LID LABEL

    Signature Care

    Quality Guaranteed

    Compare to the active ingredient in Preparation H(R) Medicated Wipes*

    MEDICATED WIPES

    HEMORRHOIDAL WIPES WITH WITCH HAZEL

    Mild, everyday wipes to ease & lessen irritation

    Soothing; Gentle; Soft

    Convenient; Easy to use

    For hemorrhoidal & vaginal care

    WITH ALOE TO SOOTHE

    48 MEDICATED WIPES

    5 in X 6 in (12.7 cm x 15.2 cm)

    2OA9131SLI

    2OA9131SLI Lid

    2OA9131R Flow wrap

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE MEDICATED WIPES HEMORRHOIDAL WIPES WITH WITCH HAZEL 
    hemorrhoidal wipes with witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-800
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PEG-75 LANOLIN (UNII: 09179OX7TB)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-800-4848 in 1 CONTAINER08/28/2020
    1252 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/28/2020
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Nice-Pak Products , Inc. (003778198)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nice-Pak Products, Inc.067900167manufacture(21130-800)