FRIDA MOM PERINEAL HEALING (WITCH HAZEL) AEROSOL, FOAM [FRIDABABY, LLC]

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FRIDA MOM PERINEAL HEALING (WITCH HAZEL) AEROSOL, FOAM [FRIDABABY, LLC]
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NDC 72705-150-01, 72705-150-02
Set ID 6a58e2a8-c4d5-4078-b5f4-28504de1f020
Category HUMAN OTC DRUG LABEL
Packager Fridababy, LLC
Generic Name
Product Class
Product Number
Application Number PART346
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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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