VANALICE- piperonyl butoxide, pyrethrum gel 
GM Pharmaceuticals, INC

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Vanalice

VanaLice Lice Killing Gel Lice Treatment - piperonyl butoxide, pyrethrum extract

8 FL OZ. 

VanaLice Lice Killing Gel Lice Treatment Drug Facts

Active ingredient

Piperonyl butoxide 3.5%

Pyrethrum extract (equivalent to 0.3% pyrethrins)

Purpose

Lice treatment

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

Do not use

  • near eyes
  • inside nose, mouth, or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you are

  • allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

When using this product

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into eyes, flush with water right away
  • scalp itching or redness may occur

Stop use and ask a doctor if

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inspect

Treat

Remove lice and their eggs (nits)

Children under 2 years: ask a doctor

Other information

Inactive ingredients

carbomer, citronellyl acetate, coconut oil, DMDM hydantoin, peg40-hydrogenated castor oil, isopropanol, isopropyl myristate, lemongrass oil, purified water, sodium hydroxide, tea tree oil tocopheryl acetate (vitamin E)

Questions or comments?

1-888-535-0305 Monday-Friday 9 AM - 5 PM CST

Step 1: Treat

VanaLice™ Lice Killing Gel

See Usage Guidelines to see how much product you will need.

NOTE:

Step 2: Remove

Lice/Nit Comb

Combing must be done AFTER use of VanaLice™ Lice Killing Gel (Step 1). Combing out eggs & nits* is an

essential step to complete lice elimination.

NOTE:

-       extra towels

-       bobby pins or hair clips

-       facial tissues or paper towels

-       regular comb for parting and detangling hair

-       detangler/conditioner to make combing easier

*Nits are empty eggshells left behind when lice hatch from eggs.

Step 3 – Control

Head Lice

Pubic (Crab) Lice

Body Lice

Daily Checking

TO PREVENT REINFESTATION:

Checklist

- Home and auto upholstery

- Bike/sport helmets

- Mattresses, pillows, pillowcases

- Coats, scarves, earmuffs, gloves

- Bed linen

- Play mats

- Towels

- Clothing

- Stuffed animals, toys

- Barrettes/hair ornaments

- Headphones

- Hair rollers

- Hats

- Combs and brushes

- Headbands

- Baseball caps

PRINCIPAL DISPLAY PANEL

NDC 58809-650-08

VanaLice™

Lice

Killing

Gel

Lice Treatment

ONE NIT COMB INCLUDED

8 FL OZ (237 mL) Principal Display Panel

VANALICE 
piperonyl butoxide, pyrethrum gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58809-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE35 mg  in 1 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
CITRONELLYL ACETATE (UNII: IZ420RT3OY)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TEA TREE OIL (UNII: VIF565UC2G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58809-650-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03108/05/2018
Labeler - GM Pharmaceuticals, INC (793000860)

Revised: 12/2023
Document Id: 0befcd6a-990f-210f-e063-6394a90a3dfc
Set id: c0205fa6-c8f4-4a28-9341-56a120843706
Version: 9
Effective Time: 20231207
 
GM Pharmaceuticals, INC