LEVIGOSP- lidocaine/benzalkoium chloride spray spray 
Topicare Management, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Description

LevigoSP is a Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13% topical anesthetic and antiseptic spray indicated to temporarily relieve minor pain.

Active Ingredients

Lidocaine HCL 2.5% --- Pain Reliever

Benzalkonium Chloride 0.13% --- First Aid Antiseptic

Purpose

For the temporary relief of minor pain or discomfort associated with minor: cuts, scrapes, burns, sunburn, skin irritations. First aid to prevent bacterial contamination or skin infections.

Warnings

For external use only.

Ask Doctor

Ask a doctor before use if you have: *deep or puncture wounds *animal bites *serious burns.

When Using This Product

When using this product: *use only as directed *do not use in or near the eyes *do not apply over large areas of the body *do not apply over raw surfaces or blistered areas.

Stop Use

Stop use and ask a doctor if: *condition worsens *symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Directions:

Adults and Children over 2 years: Clean the affected area, apply a small amount on the affected area 1 to 3 times daily. If bandaged, let dry first.

Children under 2 years: Ask a doctor.

Pregnant or breast feeding: Ask a doctor.

Dose & Aministration

Manufactured By:

Wisconsin Pharmacal Co.

1 Pharmacal Way

Jackson, WI 53037

Made in the U.S.A. of U.S. and imported materials.

Net Wt. 8 FL OZ (240mL) bottle

Questions or Comments

For questions or comments, call 1-800-635-3696.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camphor, Deionized water, Propylene Glycol

Storage & Handling

Protect from excessive heat.

Package Label. Principal Display Panel

Package Label

LEVIGOSP 
lidocaine/benzalkoium chloride spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70112-155
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.5 mg  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70112-155-08240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/08/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2018
Labeler - Topicare Management, LLC (079902303)
Establishment
NameAddressID/FEIBusiness Operations
Topicare Management, LLC079902303label(70112-155)
Establishment
NameAddressID/FEIBusiness Operations
Wisconsin Pharmacal Company, LLC800873986manufacture(70112-155)

Revised: 2/2018
Document Id: 6530ab28-1030-0364-e053-2991aa0a208b
Set id: 6530ab28-102f-0364-e053-2991aa0a208b
Version: 1
Effective Time: 20180214
 
Topicare Management, LLC