Label: FRIDA MOM PERINEAL COOLING PAD LINERS- witch hazel cloth

  • 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

    • 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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