Label: CVS PHARMACY ANTI-ITCH- hydrocortisone cream

  • 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 5, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient                                                               Purpose

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

  • PURPOSE

    Uses

    • temporary relief of external anal itching
    • temporary relief of itching associated with minor skin irritations and rashes
    • other uses of this product should be only 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.

  • WHEN USING

    When using this product

    • avoid contact with the eyes
    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not being 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.

  • INDICATIONS & USAGE

    Directions

    • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
    • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
    • children under 12 of age: do not use, consult a doctor
  • STORAGE AND HANDLING

    Other information

    • store at 20° and 25°C (68° to 77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients aloe vera leaf, butylated hydroxytoluene, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylene glycol, propylparaben, sorbitan monostearate, stearyl alcohol, water

  • DOSAGE & ADMINISTRATION

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    38364

  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-307
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-307-281 in 1 CARTON04/30/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/30/2013
    Labeler - CVS (062312574)