Label: HYDROCORTISONE 1% WITH HEALING ALOE- hydrocortisone cream

  • NDC Code(s): 69396-005-05, 69396-005-20
  • Packager: Trifecta Pharmaceuticals Usa Llc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • DRUG FACTS

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-Itch

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Uses

    temporary relieves itching associated with minor skin irritations, inflammation and rashes due to:

    ● eczema        ● seborrheic dermatitis      ● psoriasis     ● insect bites    ● poison ivy, oak, sumac      ● soaps    

    ● detergents   ● cosmetics                        ● jewelry        ● external genital and anal itching

    Other uses of this product should be only under the advice and supervision of a doctor

  • Warnings

    ●for external use only ● avoid contact with the eyes

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

    ● Stop using this product and ask a doctor ● in case of bleeding

    ● if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

    ● before you begin using any other hydrocortisone product

    Do not use this product and ask a doctor

    ● if you have a vaginal discharge ● before treating diaper rash ● before using on children under 2 years of age

    For External Anal Itching Users: ● do not exceed the recommended daily dosage unless directed by a doctor

    ● in case of bleeding, consult a doctor promptly

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

    ● children under 12 years of age: consult a doctor

    Before using any medication, read all label directions. Keep this carton. It contains important information.

  • Directions

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

    ●gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

    ●adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.

    ●children under 12 years of age: do not use, consult a doctor.

  • Inactive ingredients

    Aloe barbadensis leaf juice, ethylparaben, glycerin, glycerol monostearate, hexadecanol, mineral water, octadecanol, petrolatum, purified water, sodium dodecyl sulfate

  • Other information

    ● to open: unscrew cap and pull tab to remove foil seal

    ● if seal has been broken, do not use this product. Return product to the Store where you bought it

    ● store at controlled room temperature 15°-30°C ( 59 °- 86 °F)

    see carton or tube crimp for lot number and expiration date

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL 33301 USA

    Product of PRC

    www.trifecta-pharma.com

  • Packaging

    Hydrocortisone new1

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 1% WITH HEALING ALOE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-005
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-005-201 in 1 BOX12/23/2015
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69396-005-051 in 1 BOX08/23/2016
    215 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/23/2015
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)