ORCA PAIN RELIEVER PUTTY WITH MENTHOL- menthol paste

ORCA Pain Reliever Putty with Menthol by

Drug Labeling and Warnings

ORCA Pain Reliever Putty with Menthol 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 1.6%

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: Allow product dissolve slowly in the mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor

• Children under 12 years of age: Consult a dentist or doctor.

Other information

• Do not use if outer package is broken, cut or torn.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carthamus Tinctorius (Safflower) Seed Oil, Chamomilla Recutita (Matricaria) Flower Extract, Cinnamomum Zeylanicum Bark Oil, Elettaria Cardamomum Seed Oil, Eugenol, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Guaiacol, Maltodextrin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Xanthan Gum, Xylitol

Questions?

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

Package Labeling: 82939-001-01

INGREDIENTS AND APPEARANCE

ORCA PAIN RELIEVER PUTTY WITH MENTHOL 
menthol paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82939-001
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	8.4 mg  in 0.525 g

Inactive Ingredients
Ingredient Name	Strength
CARDAMOM OIL (UNII: JM0KJ091HZ)
CHAMOMILE (UNII: FGL3685T2X)
CINNAMON OIL (UNII: E5GY4I6YCZ)
CLOVE OIL (UNII: 578389D6D0)
GLYCERIN (UNII: PDC6A3C0OX)
GUAIACOL (UNII: 6JKA7MAH9C)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SAFFLOWER OIL (UNII: 65UEH262IS)
TEA TREE OIL (UNII: VIF565UC2G)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82939-001-01	1 in 1 PACKAGE	09/15/2022	12/20/2024
1		4.2 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 82939-001-02	1 in 1 BLISTER PACK	09/15/2022
2		7 g in 1 JAR; 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)