Label: ANTI-ITCH VULVA CREAM 1 HYDROCORTISONE ACETATE- hydrocortisone acetate cream

  • NDC Code(s): 82637-9455-1
  • Packager: The Honey Pot Company LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 26, 2022

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  • Drug Facts

  • Active Ingredient

    Hydrocortisone Acetate 1%

    Purpose

    Anti-Itch

  • Uses:

    For the temporary relief of external feminine itching.

  • Warnings:

    For external use only

    When using this product:

    avoid contact with eyes.

    Stop use and ask doctor if:

    • Condition worsens
    • If symptoms persist for more than 7 days, or clear up and reoccur again within a few days

    Do not use if:

    you have vaginal discharge. Consult a physician.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions:

    Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: Consult a doctor

  • Inactive Ingredients:

    Adansonia Digitata Seed Oil, Allantoin, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C10-18 Triglycerides, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylhydroxamic Acid, Caprylyl Glyceryl Ether, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalool, Melia Azadirachta Seed Oil, Mentha Piperita (Peppermint) Oil, Myristyl Alcohol, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Propolis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Phytate, Sodium Stearoyl Lactylate, Steareth-30, Stearic Acid, Steary Alcohol, Sucrose Palmitate, Theobroma Cacao (Cocoa) Seed Butter, Water, Xanthan Gum

  • Questions:

    For questions and general information visit us at www.thehoneypot.co/contact

  • Package Labeling:

    Label

    inner_labek

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH VULVA CREAM 1 HYDROCORTISONE ACETATE 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82637-9455
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCERYL ETHER (UNII: MI97BW74XZ)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    STEARETH-30 (UNII: 5776GCL1DG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SUCROSE PALMITATE (UNII: 3OSQ643ZK5)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82637-9455-11 in 1 CARTON03/01/2022
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2022
    Labeler - The Honey Pot Company LLC (045600502)
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