Label: ASSURED- hydrocortisone cream

  • NDC Code(s): 55621-018-28
  • Packager: Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 25, 2023

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

  • ACTIVE INGREDIENT

    Active ingredients

    Hydrocortisone 1%

  • PURPOSE

    Purpose

    Anti-itch

  • INDICATIONS & USAGE

    Uses

    •temporarily relieves itching ssociated with minor skin

    irritation, inflammation and rashesdue to:

    •eczema      •psoriasis      •poison ivy, oak, sumac

    •insect bites   •detergents   •jewelry

    •cosmetics   •soaps   •seborrheic dermatitis

    •temporarily relieves external anal and genital itching

    •other uses of this product should be under advice and

    supervision of a doctor

  • WARNINGS

    . Warnings. For external use only

    •in the genital area if you have a vaginal Do not use

    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 rectum by using fingers or

    any mechanical device or applicator.

    Stop use and ask a doctor if

    •condition worsens, symptoms persist for more than 7 days

    or clear up and occur again within a few days, and do not

    begin use of any other hydrocortisone product unless you

    have asked a doctor.   •rectal bleeding occurs.

  • KEEP OUT OF REACH OF CHILDREN

    . If swallowed, get medical Keep out of reach of children

    help or contract a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • : for relieving of skin irritation, inflammation, 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

    • s: for external anal and genital itching, adult

    •when practical, clean the affected area with mild soap

    and warm water and rinse thoroughly

    •gently dry by patting or blotting with toilet tissue or 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

  • STORAGE AND HANDLING

    Other information

    •store at room temperature 68° - 77° F (20° - 25° C)

  • INACTIVE INGREDIENT

    aloe barbadensis leaf juice, cetyl alcohol, Inactive ingredients

    dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,

    isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,

    phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic

    acid, tocopherol, water, zingiber officinale (ginger) root extract

  • QUESTIONS

    1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55621-018
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    GINGER (UNII: C5529G5JPQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55621-018-281 in 1 CARTON05/25/2018
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/25/2018
    Labeler - Zhejiang Jingwei Pharmaceutic Al Co., Ltd. (530876549)