Label: AQUANIL HC- hydrocortisone lotion

  • NDC Code(s): 0096-0732-04, 0096-0732-15
  • Packager: Person and Covey
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • Active Ingredient

    Hydrocortisone

  • Stop Use and Ask a Doctor

    Stop use and ask a doctor if:

    -Condition worsens

    -If symptoms persit for more than 7 days or clear up and occur again within a few days. Discocntinue 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 the Reach of Children

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

  • Purpose

    Antipruritic (Anti-itch)

  • 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 ddoctor.

    -Store away from excessive heat or cold.

  • Inactive Ingredients

    Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Laureth Sulfate, Stearyl Alcohol, Simethicone, Xanthan Gum

  • Questions?

    Questions? Please call (800) 423-2341

  • Uses

    For the temporary relief of minor skin irritations, inflamaations, 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.

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

  • Package Label. Principal Display Panel

    Aquanil HC

  • INGREDIENTS AND APPEARANCE
    AQUANIL HC 
    hydrocortisone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0732
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0096-0732-04118 g in 1 BOTTLE; Type 0: Not a Combination Product01/08/1995
    2NDC:0096-0732-1516 g in 1 BOTTLE; Type 0: Not a Combination Product01/08/199501/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/08/1995
    Labeler - Person and Covey (008482473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Person and Covey008482473manufacture(0096-0732)
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