Label: ANCALIMA HYDROCORTISONE CREAM- hydrocortisone cream

  • NDC Code(s): 73014-3050-2, 73014-3050-3, 73014-3050-6
  • Packager: ANCALIMA LIFESCIENCES LIMITED
  • 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 December 7, 2021

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

  • Active Ingredient

    Hydrocortisone Acetate USP (1% w/w)

  • Purpose

    Anti-itch

  • Uses

    ■ for temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

  • Warnings

    For external use only

  • Do not use

    ■ in the eyes ■ for diaper rash ■ if you have vaginal discharge ■ more than the recommended dosage

  • Ask a doctor before use

    ■ if you are pregnant or breast feeding

  • Stop use and ask a doctor if

    ■ the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

  • 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 over 2 years of age

    ■ apply evenly to affected area no more than 3 to 4 times daily

    ■ children under 2 years of age

    ■ do not use, consult a doctor

    ■ adults and children over 2 years of age

    ■ apply evenly to affected area no more than 3 to 4 times daily

    ■ children under 2 years of age

    ■ do not use, consult a doctor

    Adults

    ■ when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly

    ■ gently dry, patting or blotting with bathroom tissue or soft cloth before applying

    ■ apply externally to the area up to 6 times a daily or after a bowel movement

    ■ after application discard pad

    ■ do not flush in toilet

  • Other information

    ■ store at 20-25C (68-77F)

    ■ avoid excessive heat and humidity

  • Inactive Ingredients

    cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, White white soft paraffin

  • PRINCIPAL DISPLAY PANEL

    Principal & Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    ANCALIMA HYDROCORTISONE CREAM 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73014-3050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    CETETH-20 (UNII: I835H2IHHX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73014-3050-20.9 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
    2NDC:73014-3050-328.3 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
    3NDC:73014-3050-6454 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/08/2019
    Labeler - ANCALIMA LIFESCIENCES LIMITED (676760093)