SUMMERS LABS (as PLD) - VANOXIDE (11086-032)

VANOXIDE HC- benzoyl peroxide, 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.

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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.

VHC-25G-carton

VHC-25G-label

VANOXIDE HC
benzoyl peroxide, hydrocortisone lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:11086-032
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11086-032-01	25 g in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2009

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		11/01/2009

Labeler - Summers Laboratories Inc (002382612)