Vanoxide
FDA Label NDC 11086-032

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summers Laboratories Inc for the product Vanoxide (NDC 11086-032). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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.

Otc - 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.

Package Label.Principal Display Panel

Vhc-25g-carton (Vhc 25g Carton)

Vhc-25g-carton (Vhc 25g Carton)

Vhc-25g-label (Vhc 25g Label)

Vhc-25g-label (Vhc 25g Label)

* Please review the disclaimer below.