VANOXIDE HC- benzoyl peroxide, hydrocortisone lotion

VANOXIDE by

Drug Labeling and Warnings

VANOXIDE by is a Prescription medication manufactured, distributed, or labeled by Summers Laboratories Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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: 11086-032-01	25 g in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2009

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)