OMEZA LAVAGE- lidocaine oil

Omeza Lavage by

Drug Labeling and Warnings

Omeza Lavage by is a Otc medication manufactured, distributed, or labeled by Omeza LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Lidocaine 0.8%

Purpose

External analgesic

Use

For the temporary relief of pain

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces or blistered areas
• on puncture wounds
• do not use if you are allergic to lidocaine or any of the inacitve ingredients listed below

When using this product

• use only as directed. Read and follow all directions and warnings on this carton.
• do not allow contact with the eyes

Stop use and ask a doctor if

• allergic reaction occurs
• condition worsens or if symptoms persist for more than 7 days
• symptoms clear up and return within a few days
• redness, irritation, swelling, pain or other symptoms begin or increase

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children 

and pets. If swallowed, get medical help or contact a Poison Control Center immediately 

Directions

Adults and children 12 years and older: Apply a thin layer to affected area every 8 to 12 hours.

Children under 12 years: Consult a physician before use.

Instructions for use

• clean and dry affected area
• snap open top of vial
• apply a thin layer to affected area
• discard vial with any excess or unused dose
• wash hands thoroughly after applying

Other information

• Do not use if package is damaged or open.
• protect from freezing or excessive heat
• store at 68°-77°F (20°-25°C).

Inactive ingredients

Caprylic Fatty Acid, Caprylic/Capric Triglyceride, Cetyl Esters NF, Cod Liver Oil, Glyceryl Monolaurate, Hempseed Oil, Palm Oil

Questions?

Call toll-free 888-886-6392 or visit www.omeza.com

Package Labeling:

INGREDIENTS AND APPEARANCE

OMEZA LAVAGE 
lidocaine oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73033-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ESTERS WAX (UNII: D072FFP9GU)
COD LIVER OIL (UNII: BBL281NWFG)
GLYCERYL LAURATE (UNII: Y98611C087)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PALM OIL (UNII: 5QUO05548Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73033-001-14	14 in 1 BOX	04/15/2019
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	04/15/2019

Labeler - Omeza LLC (057694073)