ORCA COMPLETE MENTHOL PAIN RELIEVER- menthol liquid

ORCA Complete Menthol Pain Reliever by

Drug Labeling and Warnings

ORCA Complete Menthol Pain Reliever by is a Otc medication manufactured, distributed, or labeled by ORCA Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Menthol 2%

Purpose

oral pain reliever

Use

• for the temporary relief of pain due to minor irritation or injury of the mouth and gums

Warnings

Do not use

• this product for more than 7 days unless directed by a dentist or doctor.

When using this product

• do not exceed recommended dosage.

Stop use and ask a doctor if

• sore mouth symptoms do not improve in 7 days 
• irritation, pain, or redness persists or worsens 
• swelling, rash, or fever develops

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact Poison Control Center right away.

Directions

• Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar resorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Guaze strip requires removal. Orca Foam soaked sponge will resorb and does not require removal.
• Children under 12 years of age should be supervised in use of this product.
• Children under 12 years of age: Consult a dentist or doctor.

Other information

• Do not use if tamperproof seal is not intact at time of first use.

Inactive ingredients

Clove oil, glycerin, guaiacol, oregano oil, peppermint oil.

Questions?

1-970-401-1138 MON-FRI 8 AM to 3 PM (CST)

Package Labeling: 82939-000-02

INGREDIENTS AND APPEARANCE

ORCA COMPLETE MENTHOL PAIN RELIEVER 
menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82939-000
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
GUAIACOL (UNII: 6JKA7MAH9C)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82939-000-01	1 in 1 BOX	09/15/2022	08/31/2025
1		10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
2	NDC: 82939-000-02	1 in 1 BOX	09/15/2023
2		13 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/15/2022

Labeler - ORCA Products, LLC (117716283)

Registrant - ORCA Products, LLC (117716283)