Label: FRIDA MOM PERINEAL HEALING- witch hazel aerosol, foam

  • NDC Code(s): 72705-150-01, 72705-150-02
  • Packager: Fridababy, 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 January 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Witch Hazel 50%

  • Purpose

    Astringent

  • Uses

    • Helps relieve pain and swelling from hemorrhoids and childbirth.
    • Temporary relief from:
      • Irritation
      • Burning
      • Discomfort
  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • 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

    • Rectal 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

    • Cleanse the affected area using a peri bottle or mild soap and warm water.
    • Add foam on top of each new pad or pad liner for healing relief.
    • Children under 12 years of age: consult a doctor before use.
  • Other information

    • Store at room temperature
    • Single use per wipe
  • Inactive ingredients

    water, glycerin, alcohol, sodium lauroamphoacetate, chamomilla recutita extract, caprylic/capric triglyceride, tocopherol, phenoxyethanol, benzoic acid, dehydroacetic acid, sodium benzoate, citric acid, mentha piperita oil, sodium citrate

  • PRINCIPAL DISPLAY PANEL - 5 fl. oz. Bottle Carton

    frida mom

    Perineal
    Healing Foam

    Cooling pain relief
    from vag to tush

    Foam...

    Witch Hazel

    Speeds healing
    Reduces swelling
    No harsh chemicals

    Postpartum
    Net 5 fl. oz.

    PRINCIPAL DISPLAY PANEL - 5 fl. oz. Bottle Carton
  • INGREDIENTS AND APPEARANCE
    FRIDA MOM PERINEAL HEALING 
    witch hazel aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel0.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72705-150-021 in 1 CARTON05/01/2019
    1NDC:72705-150-01141.75 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34605/01/2019
    Labeler - Fridababy, LLC (783729598)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fischer Pharmaceuticals Ltd.600410514MANUFACTURE(72705-150)
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