Label: LINCOLN- hydrocortisone acetate 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 April 5, 2016

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

  • Drug Facts

    Hydrocortisone Acetate USP (1 % W/W)

  • Drug Facts

    Anti-Itch

  • Drug Facts

    for external use only

  • INDICATIONS & USAGE

    USES

    • For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy position sumac, poison oak, soaps, detergents, cosmetics, jewelry, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor
  • Drug Facts

    • in the eyes
    • for diaper rash
    • if you have a vaginal discharge
    • more than the recommended dosage
  • Drug Facts

    If you are pregnant or breast- feeding

  • Drug Facts

    • the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • Drug Facts

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

    For Itching of skin irritation, inflammation and rashes:

    • adults and children over 2 years of age
    • apply evenly to affected area no more than 3 to 4 times daily

    Children under 2 years of age

    • Do not use, consult a doctor

    For External anal and genital itching, adults:

    • when practical cleanse the affected area with mild soap and warm water and rinse thoroughly
    • gently dry, patting or blotting with bathroom tissue or soft cloth before applying
    • apply externally to the area upto 6 times daily or after each bowel movement
    • after application, discard pad
    • do not flush in toilet
  • Drug Facts

    Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

  • Drug Facts:

    • store at room temperature 68-77 F (20°-25°C)
    • avoid excessive heat and humidity
  • Package Label

    principal display panel

  • INGREDIENTS AND APPEARANCE
    LINCOLN 
    hydrocortisone acetate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3050
    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
    CHLOROCRESOL (UNII: 36W53O7109)  
    CETETH-20 (UNII: I835H2IHHX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69636-3050-20.9 g in 1 PACKET; Type 0: Not a Combination Product05/23/2013
    2NDC:69636-3050-328.3 g in 1 TUBE; Type 0: Not a Combination Product05/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/23/2013
    Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-3050)