FRIDA MOM PERINEAL COOLING PAD LINERS (WITCH HAZEL) CLOTH [FRIDABABY, LLC]

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FRIDA MOM PERINEAL COOLING PAD LINERS (WITCH HAZEL) CLOTH [FRIDABABY, LLC]
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NDC 72705-100-01
Set ID a461ff3d-e115-4f15-a545-bacb502ff6cd
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

    • Remove one Pad Liner from pouch and place on top of maxi pad.
    • Close lid after use to retain moisture.
    • Replace Pad Liner with each maxi pad change.
  • Other information

    • Store at room temperature.
    • Close lid after every use to retain moisture.
    • Discard after every use.
    • Not flushable.
  • 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, menthyl lactate, sodium citrate

  • PRINCIPAL DISPLAY PANEL - 24 Liner Pouch

    frida mom

    Perineal Cooling
    Pad Liners

    Full-coverage
    medicated vag pads

    Witch Hazel

    Speeds healing | Reduces swelling | No harsh chemicals

    Postpartum
    24 pad liners

    PRINCIPAL DISPLAY PANEL - 24 Liner Pouch
  • INGREDIENTS AND APPEARANCE
    FRIDA MOM PERINEAL COOLING PAD LINERS 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel0.50 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)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72705-100-0124 in 1 POUCH; Type 0: Not a Combination Product05/01/2019
    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(72705-100)
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