Label: FRIDA MOM POSTPARTUM RECOVERY ESSENTIALS- witch hazel kit

  • NDC Code(s): 72705-100-01, 72705-150-01, 72705-200-01
  • 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

    Perineal Cooling Pad Liners

    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

  • SPL UNCLASSIFIED SECTION

    Perineal Healing Foam

    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 - Kit Carton

    frida mom

    Postpartum Recovery
    Essentials Kit

    The bathroom recovery regimen you
    won't want to pee without

    Trust us, your vagina will thank you

    Cover

    Disposable Postpartum Underwear
    4 pairs

    Chill + Absorb

    Instant Ice Maxi Pads
    4 pads

    Soothe + Relieve Pain

    Perineal Cooling Pad Liners
    24 witch hazel liners

    Perineal Healing Foam
    witch hazel net 5 fl. oz.

    Postpartum

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    FRIDA MOM POSTPARTUM RECOVERY ESSENTIALS 
    witch hazel kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72705-200
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72705-200-011 in 1 CARTON05/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 POUCH 24 
    Part 21 BOTTLE, PUMP 141.75 g
    Part 1 of 2
    FRIDA MOM PERINEAL COOLING PAD LINERS 
    witch hazel cloth
    Product Information
    Item 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 HAZEL0.5 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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34605/01/2019
    Part 2 of 2
    FRIDA MOM PERINEAL HEALING 
    witch hazel aerosol, foam
    Product Information
    Item 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:72705-150-01141.75 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
    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(72705-200)
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