OMEZA LIDOCAINE LAVAGE- lidocaine oil
Omeza 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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Omeza Lidocaine Lavage

Drug Facts

Active ingredients

Lidocaine 0.8%

Purpose

pain relieving

Use

for the temporary relief of pain and itching.

Warnings

For external use only

When using this product

Avoid contact with eyes.

Do not use

in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days.

Keep out of reach of children.

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

Directions

Adults and children 2 years and older. Apply to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult a doctor.

Inactive ingredients

caprylic/capric triglyceride, caprylic fatty acid, cetyl palmitate, cod liver oil, glyceryl monolaurate, hempseed oil, palm oil

Questions or Comments

1-888-886-6392

Package Labeling:

Bottle

OMEZA LIDOCAINE LAVAGE
lidocaine oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73033-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
COD LIVER OIL (UNII: BBL281NWFG)
GLYCERYL LAURATE (UNII: Y98611C087)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PALM OIL (UNII: 5QUO05548Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73033-002-00	10 in 1 BOX	12/01/2021
1		1 in 1 POUCH
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/01/2021

Labeler - Omeza LLC (118802035)