Label: EQUATE HYDROCORTISONE- 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 February 13, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Antipruritic (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. 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

    • 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

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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: ask a doctor
    • for external anal and genital itching, adults:
      • 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
      • 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 15 to 30°C (59 to 86°F)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.
  • Inactive ingredients

    aloe barbadensis leaf juice, ammonium acryloyldimethyltaurate/VP copolymer, bees wax, carbomer, ceteareth-6, cetyl alcohol, citric acid, coconut oil, corn starch, dimethicone, disodium EDTA, glycerin, isopropyl palmitate, methylparaben, mineral oil, propylene glycol, propylparaben, shea butter, sodium citrate, sodium lauryl sulfate, tocopheryl (vitamin E) acetate, white petrolatum, USP purified water

  • Questions or comments?

    1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: Walmart Inc.,
    Bentonville, AR 72716

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 79903-092-01

    equate™

    Compare to
    Cortisone•10®
    Intensive
    Healing Formula
    active
    ingredient*

    MAXIMUM STRENGTH

    Hydrocortisone
    Cream 1%
    Intensive Healing
    Formula

    Antipruritic (Anti-Itch)
    With Antioxidants

    Relieves Itch Fast

    • Rashes & Redness
    • Eczema & Psoriasis
    • Inflammation & Irritation
    • Dry, Itchy Skin

    Contains Healing
    Moisturizers Enriched
    With Vitamin E

    NET WT 1 OZ (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    EQUATE HYDROCORTISONE 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-092
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ammonium acryloyldimethyltaurate/VP copolymer (UNII: W59H9296ZG)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ceteareth-6 (UNII: 2RJS3559D3)  
    cetyl alcohol (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    coconut oil (UNII: Q9L0O73W7L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    glycerin (UNII: PDC6A3C0OX)  
    isopropyl palmitate (UNII: 8CRQ2TH63M)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    shea butter (UNII: K49155WL9Y)  
    sodium (UNII: 9NEZ333N27)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-092-011 in 1 CARTON11/18/2021
    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 finalpart34811/18/2021
    Labeler - WalMart (051957769)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(79903-092)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!