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
  • 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 January 21, 2020

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

  • 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 Product01/08/1995
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/08/1995
    Labeler - Person and Covey (008482473)
    Establishment
    NameAddressID/FEIBusiness Operations
    Person and Covey008482473manufacture(0096-0732)