Label: ANTI-ITCH CREAM- hydrocortisone cream 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 August 19, 2022

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  • Active ingredients (in each packet)

    Hydrocortisone acetate 1%

  • Purpose

    anti-itch cream

  • Uses

    temporarily relieves itching associated with minor skin irritations and rashes due to:

    • eczema
    • insect bites
    • poison ivy, oak, or sumac
    • soaps, detergents, or cosmetics
    • jewelry
  • Warnings

    for external use only

  • Do not use

    • with any other hydrocortisone product unless you have consulted a doctor
    • for the treatment of diaper rash, consult a doctor
  • When using this product

    avoid contact with eyes

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Adults and children 2 years and over - apply to affected area not more than 3 to 4 times daily

    children under 2 years - do not use

  • Other information

    • do not use if package is torn, cut or opened
    • store at room tempreature (do not freeze)
    • see packet for Lot Number and expiration date
  • Inactive ingredients

    cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

  • Questions

    1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM

  • PRINCIPAL DISPLAY PANEL

    Hydrocortisone

    1% hydrocortisone anti-itch cream

    Net wt per pkt 1/32 oz (0.9 g)

    20 pkts per box

    Front Panel

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH CREAM 
    hydrocortisone cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82940-220(NDC:42961-220)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE0.01 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82940-220-0120 in 1 BOX08/19/2022
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/19/2022
    Labeler - Shares inc (081533663)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shares Inc081533663repack(82940-220)
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