Label: HYDROCORTISONE lotion

  • 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 March 10, 2023

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  • Active Ingredient

    Hydrocortisone 1% (Micronized)

  • Purpose

    Antipruritic (Anti-itch)

  • Use

    For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

    • insect bites
    • eczema
    • psoriasis
    • soaps
    • detergents
    • cosmetics,
    • jewelry,
    • poison oak,
    • poison sumac
    • Other uses of this product should be undertaken only under the advice and supervision of a doctor.
  • Warnings

    For external use only.

  • When using this product

    Do not get into eyes. If contact occurs, rinse thoroughly with water.

  • Stop use and ask a doctor if

    • Condition worsens
    • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
    • Do no use for diaper rash. Consult a doctor.
  • Keep out of Reach of Children

    Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • Shake will before using.
    • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
    • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.
  • Other Information

    • Store away from excessive heat or cold.  Shake well before using.

  • Inactive Ingredients

    Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

  • Questions?

    Please Call 1(877) 225-6999

  • SPL UNCLASSIFIED SECTION

    Manufactured for:

    Akron Pharma, Inc.
    Fairfield, NJ 07004

    Rev. 03/19

    Manufactured in U.S.A

  • PRINCIPAL DISPLAY PANEL

    lotion

  • INGREDIENTS AND APPEARANCE
    HYDROCORTISONE 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0120-11 in 1 CARTON05/17/2021
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/17/2021
    Labeler - AKRON PHARMA INC (067878881)
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