VANOXIDE HC

VANOXIDE HC- benzoyl peroxide and hydrocortisone lotion
Summers Laboratories Inc

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 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 0.5 g in 100 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:11086-032-01 25 g in 1 BOTTLE None

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)

Revised: 07/2021 Summers Laboratories Inc