Label: VANOXIDE HC- benzoyl peroxide, hydrocortisone lotion

  • NDC Code(s): 11086-032-01
  • Packager: Summers Laboratories Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated October 9, 2023

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    BENZOYL PEROXIDE 5%

    HYDROCORTISONE 0.5%

  • WARNINGS

    Apply with caution on neck and/or other sensitive areas. There may be a slight transitory stinging or burning sensation on initial applications. Colored or dyed garments and linens may be bleached by the action of benzoyl peroxide. If irritation or sensitivity is
    observed, discontinue use and consult your physician.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    TO THE PHARMACIST:
    Prior to dispensing, add powder content of vial* to lotion. Shake bottle thoroughly to disperse completely. After addition of powder, place expiration date of 3 months on the bottle.
    *Benzoyl-Pak™

  • INDICATIONS & USAGE

    • Keep away from eyes. FOR TOPICAL USE ONLY.Not for ophthalmic, oral or intravaginal use.
    • Shake well before using.
    • Keep tightly closed.
    • Store at room temperature. 20°-25° C (68°-77° F). Do not freeze.
  • PRINCIPAL DISPLAY PANEL

    VHC-25G-carton

    VHC-25G-label

  • INGREDIENTS AND APPEARANCE
    VANOXIDE   HC
    benzoyl peroxide, hydrocortisone lotion
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:11086-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE0.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11086-032-0125 g in 1 BOTTLE; Type 0: Not a Combination Product11/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2009
    Labeler - Summers Laboratories Inc (002382612)
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