Label: CVS HEALTH MAXIUM STRENTGH CORTISONE- hydrocortisone lotion

  • 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 January 15, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient                                                        Purpose

    Hydrocortisone 1%.................................................. Anti-itch

  • PURPOSE

    Uses

    • temporarily relieves external feminine itching
    • other uses of this product should only be used under the advice and supervision of a doctor
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • for the treatment of diaper rash. Consult a doctor.
    • if you have vaginal discharge. 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 more than directed unless told to do so by a doctor
  • STOP USE

    Stop use and ask a doctor if

    • condition worsens, symptoms persist 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 asked 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.

  • INDICATIONS & USAGE

    Directions

    • shake well before use
    • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
    • adults and children 12 years of age and older: apply a fingertip amount (approxametly 1-inch strip) to affected area not more than 3 to 4 times daily
    • children under 12 years: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature
    • Lot No. & Exp. Date: see bottom of container
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, butylated hydroxytoluene, ceteth-20, cetyl alcohol, lactic acid, mineral oil, propylene glycol, purified water, sorbitan monostearate, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    CVS Pharmacy, Inc.

    One CVS Drive

    Woonsocket, RI 02895

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    54301.1

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MAXIUM STRENTGH CORTISONE 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-774
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-774-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/25/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2016
    Labeler - CVS Pharmacy (062312574)