Label: REPHRESH COOLING- hydrocortisone spray

  • 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 June 4, 2018

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  • 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 (UNII: G0R4UBI2ZZ)  
    CITRONELLYL METHYLCROTONATE (UNII: K61O222P3D)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LACTIC ACID (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 CARTON06/01/2018
    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 not finalpart34806/01/2018
    Labeler - Church & Dwight Co., Inc. (001211952)
    Registrant - Church & Dwight Co., Inc. (001211952)
    Establishment
    NameAddressID/FEIBusiness Operations
    FLEET LABORATORIES LTD217269489manufacture(10237-774)
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