Omeza Licodaine Pain & Itch Relief Oil

Omeza Licodaine Pain and Itch Relief Oil by

Drug Labeling and Warnings

Omeza Licodaine Pain and Itch Relief Oil by is a Otc medication manufactured, distributed, or labeled by Omeza LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OMEZA LICODAINE PAIN AND ITCH RELIEF OIL- 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 Licodaine Pain & Itch Relief Oil

Drug Facts

Active ingredient

Lidocaine 0.80%

Purpose

External analgesic

Use

for the temporary relief of pain and itching associated with:

 minor cuts  sunburn  minor scrapes minor burns  insect bites  minor skin irritations

Warnings

For external use only

Do not use

• in large quantities, particularly over raw surfaces or blistered areas
• on puncture wounds
• if you are allergic to lidocaine or any of the inactive ingredients

When using this product

• use only as directed
• avoid contact with 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 ingested, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 12 years and older: Apply thin layer to affected area every 8 to 12 hours.
• Children under 12 years: Consult a physician before use.

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/capric triglyceride, caprylic fatty acid, 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:

OMEZA LICODAINE PAIN AND ITCH RELIEF OIL 
lidocaine oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73033-004
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: 73033-004-14	14 in 1 BOX	11/01/2020	12/31/2022
1		2.3 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 not final	part348	11/01/2020	12/31/2022

Labeler - Omeza LLC (057694073)

Revised: 9/2022

Document Id: e8491335-6eff-630d-e053-2995a90ae956

34390-5

Set id: e4c7d942-e37c-492c-9160-3223995007c3

Version: 3

Effective Time: 20220909