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NDC 70112-0155-08 LevigoSP .13; 2.5 mg/mL; mg/mL Details

LevigoSP .13; 2.5 mg/mL; mg/mL

LevigoSP is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Topicare Management, LLC. The primary component is BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	70112-0155
Product ID	70112-155_730382c5-b001-6914-e053-2991aa0a8a0d
Associated GPIs	90859902850918
GCN Sequence Number	061747
GCN Sequence Number Description	lidocaine HCl/benzalkonium chl SPRAY 2.5%-0.13% TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	97533
HICL Sequence Number	010610
HICL Sequence Number Description	LIDOCAINE HCL/BENZALKONIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	LevigoSP
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine/benzalkoium chloride spray
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	.13; 2.5
Active Ingredient Units	mg/mL; mg/mL
Substance Name	BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Labeler Name	Topicare Management, LLC
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70112-0155-08 (70112015508)

Pricing Information	N/A
NDC Package Code	70112-155-08
Billing NDC	70112015508
Package	240 mL in 1 BOTTLE, SPRAY (70112-155-08)
Marketing Start Date	2018-03-08
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 67cb2d7f-47a0-c7e8-e053-2991aa0a1951 Details

Description

LevigoSP is a Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13% topical anesthetic 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 & Administration

Manufactured By:

Wisconsin Pharmacal Co.

1 Pharmacal Way

Jackson, WI 53037

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

Manufactured For:

Topicare Therapeutics

1925 Longmire Rd.

Bldg. 2

Conroe, TX 77304

Net Wt. 5 FL OZ (150Ml) bottle

Questions or Comments

For questions or comments, call 1-936-703-5474.

Inactive Ingredients

Camphor, Deionized water, Propylene Glycol

Storage & Handling

Protect from excessive heat.

Package Label. Principal Display Panel

INGREDIENTS AND APPEARANCE

LEVIGOSP

lidocaine/benzalkoium chloride spray spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70112-155
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 mg in 1 mL
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70112-155-05	150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/19/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/19/2018

Labeler - Topicare Management, LLC (079902303)

Name	Address	ID/FEI	Business Operations
Establishment
Topicare Management, LLC		079902303	label(70112-155)

Name	Address	ID/FEI	Business Operations
Establishment
Wisconsin Pharmacal Company, LLC		800873986	manufacture(70112-155)

Revised: 8/2018

Document Id: 730382c5-b001-6914-e053-2991aa0a8a0d

Set id: 67cb2d7f-47a0-c7e8-e053-2991aa0a1951

Version: 2

Effective Time: 20180809