Label: ALOE CORT- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone USP 1%

  • Purpose

    Antipruritic cream

  • Uses

    For the temporary relief of itching from minor skin irritations, and rashes

    • Other uses of this product should be only under the supervision of a doctor.
  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily, or as directed. Consult a physician for children under 2 years of age.

  • Warnings

    • For external use only
    • Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days, stop use of this product and consult a physician
    • Do not use for treatment of diaper rash

    • Keep out of reach of children. If swallowed, seek professional assistance or contact a Poison Control Center immediately.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Beeswax, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Dimethicone, Glycerin, Imidazolidinyl Urea, Methylparaben, PPG-2 Myristyl Ether Propionate, Polysorbate-60, Propylparaben, Purified Water, Squalane, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL - 57 g Tube Label

    DERMA
    TOPIX

    aloe cort cream

    Hydrocortisone USP, 1%

    Net wt. 2 oz. (57g)

    Topix Pharmaceuticals, Inc. • N. Amityville, NY 11701

    DERMA
    TOPIX

    PRINCIPAL DISPLAY PANEL - 57 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ALOE CORT 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.57 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-108-5757 g in 1 TUBE; Type 0: Not a Combination Product02/27/1990
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01702/27/1990
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topix Pharmaceuticals, Inc.117745066PACK(51326-108)
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