Label: MAKESENSE MAXIMUM STRENGTH- 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 August 8, 2016

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

  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    ■ for temporary relief of itching associated with minor skin irritations and rashes due to: ■ eczema  ■ seborrheic dermatitis ■ psoriasis ■insect bites ■ poison ivy, oak, sumac ■ soaps ■ detergents ■ cosmetics ■ jewelry ■  temporarily relieves external anal and genital itching   ■ other uses of this product should be under the advice and supervision of a doctor

  • Warnings

    For external use only

  • Do not use

    ■ in the genital area if you have vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

  • When using this product

    ■ avoid contact with eyes ■ do not use more than directed unless told to do so by a doctor ■ do not put directly into the rectum by using fingers or any mechanical device or applicator

  • Stop use and ask a doctor if

    ■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not beginuse of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    for itching of skin irritation and rashes: ■ adults and children 2 years of age and older: apply to affected
    area not more than 3 to 4 times daily ■ children under 2 years of age: ask a doctor

    for external anal and genital itching: adults: ■ when practical, clean the affected area with mild soap and water and rinse thoroughly        ■ gently dry by patting or blotting with toilet tissue or a soft cloth before applying ■ apply to affected area not more than 3 to 4 times daily ■ children under 12 years of age: ask a doctor

  • Other information

    ■ store at 68-77F (20 to 25C) ■ see carton or tube crimp for lot number and expiration date

  • Inactive Ingredients

    Cetearyl Alcohol, Disodium EDTA, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-204
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-204-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2014
    Labeler - Cherry Hill Sales Co (145959768)