Label: DRS. HYDROCORTISONE ALOE VERA- hydrocortisone cream

  • NDC Code(s): 80489-088-01, 80489-088-02
  • Packager: OL PHARMA TECH,LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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

  • ACTIVE INGREDIENT

    Hydrocortisone, USP 1%

  • PURPOSE

    Anti-itch

  • USES

    for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

    •eczema

    •insect bites

    •poison ivy

    •poison oak

    •poison ...

  • WARNINGS

    For external use only

  • DO NOT USE

    for external feminine itching if you have a vaginal discharge. Consult a doctor.
    for the treatment of diaper rash. Consult a doctor.

  • WHEN USING THIS PRODUCT

    •avoid contact with the eyes

    •do not begin the use of any other hydrocortisone product unless directed by a doctor

    •for external anal itching:

    do not use more than directed unless directed by a doctor

    do not put this product into the rectum by using fingers or any mechanical device or applicator

  • STOP USE AND ASK YOUR DOCTOR IF

    •symptoms last for more than 7 days

    •the condition gets worse

    •symptoms clear up and occur again in a few days

    •rectal bleeding occurs, consult doctor promptly

  • 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 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: do not use, consult a doctor
    • For external anal itching
    • Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

  • OTHER INFORMATION

    • Store at room temperature 59°-86°F (15°-30°C).
    • Protect from freezing.
    • Before using any medication, read all label directions. Keep carton, it contains important information.
  • INACTIVE INGREDIENTS

    cetostearyl alcohol, sodium cetostearyl sulfate, stearic acid, trolamine, mineral oil , propylene glycol, water, methyl paraben, propyl paraben, EDTA, vitamin E, Aloe vera leaf.

  • PRINCIPAL DISPLAY PANEL

    aloe vera

  • INGREDIENTS AND APPEARANCE
    DRS. HYDROCORTISONE ALOE VERA 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80489-088
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80489-088-011 in 1 CARTON01/01/2021
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:80489-088-021 in 1 CARTON01/01/2021
    249.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01601/01/2021
    Labeler - OL PHARMA TECH,LLC (021170377)
    Registrant - OL PHARMA TECH,LLC (021170377)
    Establishment
    NameAddressID/FEIBusiness Operations
    OL PHARMA TECH,LLC (Drs. pharmacy)021170377manufacture(80489-088)