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Vanoxide HC

Generic Name: benzoyl peroxide, hydrocortisone
Dosage Form: lotion

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

ACTIVE INGREDIENTS:

BENZOYL PEROXIDE 5%

HYDROCORTISONE 0.5%

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.

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™

  • 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.

VANOXIDE   HC
benzoyl peroxide, hydrocortisone lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:11086-032
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5 g  in 100 g
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE .5 g  in 100 g
Packaging
# Item Code Package Description
1 NDC:11086-032-11 1 BOTTLE in 1 BOX
1 NDC:11086-032-01 25 g in 1 BOTTLE
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 Operations
Summers Laboratories Inc 002382612 manufacture(11086-032), pack(11086-032)
Revised: 10/2014
 
Summers Laboratories Inc



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