Label: ANTI-ITCH- 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 25, 2019

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  • Active ingredient

    Hydrocortisone 1.0%

  • Purpose

    Anti-itch

  • Uses

    For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should be only under the advice and supervision of a doctor.

  • Warnings

    External use only

    Do not use

    • in eyes
    • for treatment of diaper rash
    • for feminine itching

    Stop use, ask a doctor

    • if conditions worsen or lasts more than 7 days, or clears up and occurs again within a few days
    • with use of other hydrocortisone products

    Keep out of reach of children.

    If ingested, contact a Poison Control Center right away

  • Directions

    • apply to affected area not more than 3 to 4 times daily
    • children under 2: ask a doctor
  • Inactive ingredients

    emulsifying wax, ethanol, methylparaben, mineral oil, paraffin, petrolatum, propylparaben, purified water, white wax

    Welly Health PBC, Minn., MN 55402

    1-833-BE-WELLY

  • Principal Display Panel - Welly Health Hydrocortisone Cream Pouch Label

    Welly™

    1% Hydrocortisone
    Cream

    0.9g/ 1/32 OZ

    Principal Display Panel - Welly Health Hydrocortisone Cream Pouch Label
  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72663-580
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    hydrocortisone (UNII: WI4X0X7BPJ) (hydrocortisone - UNII:WI4X0X7BPJ) hydrocortisone1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    alcohol (UNII: 3K9958V90M)  
    methylparaben (UNII: A2I8C7HI9T)  
    mineral oil (UNII: T5L8T28FGP)  
    paraffin (UNII: I9O0E3H2ZE)  
    petrolatum (UNII: 4T6H12BN9U)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    white wax (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72663-580-020.9 mL in 1 POUCH; Type 0: Not a Combination Product02/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/25/2019
    Labeler - Welly Health PCB (116766884)
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