Label: FRIDA MOM HEALING FOAM- salicylic acid aerosol, foam

  • NDC Code(s): 58443-0550-4
  • Packager: Prime Enterprises, Inc.
  • 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 April 21, 2022

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  • Active ingredients

    Witch Hazel 50%

  • Purpose

    Astringent

  • Uses

    • Helps relieve the local itching and discomfort in the perianal area.
  • 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

    Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Add foam on top of pad or pad liner. Children under 12 years of age: consult a doctor. Apply to the affected area up to 6 times daily or after each bowel movement.

  • Other information

    • Store at room temperature
  • Inactive ingredients

    Hamamelis Virginiana (Witch Hazel) Extract, Water, Glycerin, Alcohol, Sodium Lauroamphoacetate, Phenoxyethanol, Benzoic Acid, Tocopherol, Sodium Benzoate, Dehydroacetic Acid, Caprylic/Capric Triglyceride, Sodium Citrate, Mentha Piperita (Peppermint) Oil, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid

  • Frida mom Perineal Healing Foam

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    FRIDA MOM  HEALING FOAM
    salicylic acid aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL510 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALCOHOL (UNII: 3K9958V90M)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    Coloryellow (Very Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0550-4139 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/21/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/21/2022
    Labeler - Prime Enterprises, Inc. (101946028)
    Registrant - Prime Enterprises, Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(58443-0550) , pack(58443-0550) , analysis(58443-0550) , label(58443-0550)
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