Label: HYDROCORTISONELOTION- hydrocortisone lotion ointment

  • Category: HUMAN OTC DRUG LABEL

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 October 1, 2019

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  • ACTIVE INGREDIENT

    Hydrocortisone 1.0%​

  • PURPOSE

  • INACTIVE INGREDIENT

    Inactive Ingredients: Beeswax, petroleum jelly, mineral oil.

  • DOSAGE & ADMINISTRATION

  • WARNINGS

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

  • PRINCIPAL DISPLAY PANEL

    Lotion

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONELOTION 
    hydrocortisone lotion ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67516-0109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67516-0109-170.87 g in 1 PACKAGE; Type 0: Not a Combination Product01/10/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/10/2001
    Labeler - Dr. Dan's LLC (080637276)
    Registrant - Dr. Dan's LLC (080637276)