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VANOXIDE (Summers Laboratories Inc)

Available Formats

Dosage Form Package Information Links
LOTION 1 BOTTLE in 1 BOX (11086-032-11) > 25 g in 1 BOTTLE (11086-032-01) Label Information

Complete VANOXIDE Information

  • 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-Pakâ„¢


  • 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.

  • INGREDIENTS AND APPEARANCE
    VANOXIDE  HC
    benzoyl peroxide, hydrocortisone lotion
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11086-032
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g  in 100 g
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 0.5 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11086-032-11 1 in 1 BOX 11/01/2009
    1 NDC:11086-032-01 25 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 11/01/2009
    Labeler - Summers Laboratories Inc (002382612)
    Establishment
    Name Address ID/FEI Business Operations
    Summers Laboratories Inc 002382612 manufacture(11086-032) , pack(11086-032)