Label: EQUALINE ANTI ITCH- hydrocortisone ointment

  • NDC Code(s): 41163-471-64
  • Packager: United Natural Foods, Inc. dba UNFI
  • 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 1, 2023

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

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due 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 only be under the advice and supervision of a doctor
  • Warnings

    For external use only

    Do not use

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

    When using this product

    avoid contact with the 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

    condition worsens
    rectal bleeding occurs
    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

    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, 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: do not use, ask a doctor
    for external anal and genital itching, adults:
    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 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 20°-25°C (68°-77°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, white petrolatum

  • Questions or comments?

    1-855-423-2630

  • Principal Display Panel

    EQUALINE®

    Compare to Cortizone•10® active ingredient

    relieves itch fast

    • skin irritation • rashes

    • inflammation & redness

    • insect bites

    • eczema & psoriasis

    • water resistant formula

    #1 doctor recommended itch relief active ingredient

    EQUALINE®

    Compare to Cortizone•10® active ingredient

    maximum strength

    anti-itch ointment

    1% hydrocortisone anti-itch ointment

    water resistant formula

    NET WT 1 OZ (28g)

    aniti itch ointment image
  • INGREDIENTS AND APPEARANCE
    EQUALINE ANTI ITCH 
    hydrocortisone ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-471
    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)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorWHITE (clear) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-471-641 in 1 CARTON12/03/2010
    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 not finalpart34812/03/2010
    Labeler - United Natural Foods, Inc. dba UNFI (943556183)