Label: REPHRESH COOLING- hydrocortisone spray

  • NDC Code(s): 10237-774-15
  • Packager: Church & Dwight Co., Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 6, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Hydrocortisone 0.5%

  • PURPOSE

    External Analgesic/Anti-Itch

  • USE

    For the temporary relief of external feminine itching

    Other uses of this product should be only under the advice and supervision of a doctor

  • WARNINGS

    Warning(s) For external vaginal use only

    Do not use if you have vaginal discharge

  • ASK DOCTOR/PHARMACIST

    Consult a doctor if you are allergic to any ingredient in this product

  • WHEN USING

    When using this product

    Avoid contact with eyes

  • DO NOT USE

    Do not use more than directed unless told to do so by a doctor

  • STOP USE

    Stop use and ask a doctor if condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

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

  • Directions

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

    Children under 12 years of age: Do not use, consult a doctor

    When practical, cleanse and dry the affected area before application of this product

    Remove safety seal and cap

  • DOSAGE & ADMINISTRATION

    Pump 3-5 times before first use for proper dispensing

    Shake gently before applying

    Holding tube 6 inches away from vaginal are and apply using 1 quick, firm spray.

    Note: Tube is designed to spray upside down, if needed

  • OTHER SAFETY INFORMATION

    Keep away from hear or direct sunlight, store at room temperature

    Do not use if safety seal is broken or missing

  • INACTIVE INGREDIENT

    Water, Propanediol, Propylene Glycol, Pentylene Glycol, Laureth-9, Polysorbate 20, Chamomilla Recutita (Matricaria) Flower Extract, Menthyl Ethylamido Oxalate, Citronellyl Methylcrotonate, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Lactic Acid

  • QUESTIONS

    Questions? Call us at 800 833 9532 Monday through Friday 9 to 5 pm ET or visit our website at www rephresh com

  • PRINCIPAL DISPLAY PANEL

    RepHresh™ Vaginal Anti-Itch Spray

    Cooling Relief Spray

    #1 Trusted Brand

    Gynecologist Recommended

    Unscented

    0.50 FL OZ (15mL)

    0.5% Hydrocortisone

    RepHresh Spray.jpg

  • INGREDIENTS AND APPEARANCE
    REPHRESH COOLING 
    hydrocortisone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10237-774
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE500 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ)  
    CITRONELLYL METHYLCROTONATE (UNII: K61O222P3D)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    POLIDOCANOL (UNII: 0AWH8BFG9A)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MENTHYL ETHYLENE GLYCOL CARBONATE, (-)- (UNII: 4K3514B1GT)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10237-774-151 in 1 CARTON06/01/201801/31/2025
    115 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01706/01/201801/31/2025
    Labeler - Church & Dwight Co., Inc. (001211952)
    Registrant - Church & Dwight Co., Inc. (001211952)