Label: HYDROCORTISONE- hydrocortisone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 16, 2010

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

View All Sections
  • ACTIVE INGREDIENT



    Active ingredient                            Purpose

    Hydrocortisone 1%...................................External analgesic


  • PURPOSE



    Active ingredient                            Purpose

    Hydrocortisone 1%...................................External analgesic

    Uses Temporarily relieves itching associated with minor skin
    irritation and rashes due to saborrheic dermatitis and psoriasis.
    Other uses of this product should be only used under the advice
    and supervision of 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 and children 2 years and older: apply to affected areas one to four times daily

    - children under 2 years of age, do not use, consult a doctor

  • WARNINGS

    Warnings

    For external use only.

    When using this product

    - do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

    Stop use of this product and do not begin use of any other hydrocortisone product if

    - condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, unless you have consulted a doctor.

    Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center right away.

    Flammable, Keep away from fire or flame.
  • DOSAGE & ADMINISTRATION



    Directions

    - adults and children 2 years and older: apply to affected areas one to four times daily

    - children under 2 years of age, do not use, consult a doctor
  • INACTIVE INGREDIENT



    Inactive Ingredients SD Alcohol 40-B, water, propylene glycol, menthol, tocopheryl acetate,
    aloe barbadensis leaf juice, meialeuce alternilolia (tea tree) leaf oil, disodium EDTA

  • PRINCIPAL DISPLAY PANEL


    c

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE  
    hydrocortisone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    MENTHOL (UNII: L7T10EIP3A)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-318-031 in 1 CARTON
    144 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34807/16/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!