COOL RELIEF ORAL ANESTHETIC- menthol lozenge

COOL RELIEF ORAL ANESTHETIC by

Drug Labeling and Warnings

COOL RELIEF ORAL ANESTHETIC by is a Otc medication manufactured, distributed, or labeled by Ricola Ag, Ricola Ag . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Oral anesthetic

Active Ingredient (in each drop)

Menthol, 13.2 mg

Uses

temporarily relieves occasional minor irritation and pain associated with

• sore mouth
• sore throat

Warnings

Do not use

• in children under 5 years of age unless directed by a doctor

Sore throat warnings:

• if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.  These may be serious.

Keep out of reach of children.

Directions

• adults and children 6 years and older:  dissolve 1 drop slowly in the mouth.  Repeat every 2 hours as needed or as directed by a doctor
• children under 6 years: ask a doctor
• do not bite or chew

Other Information

protect from heat and moisture

Inactive Ingredients

extract of lemon balm and the Ricola herb mixture (elder, horehound, hyssop, lemon balm, linden flowers, mallow, peppermint, sage, thyme, wild thyme), colors (carrot, spirulina), flavors (lemon-thyme, peppermint), starch syrup, sugar

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOL RELIEF ORAL ANESTHETIC 
menthol lozenge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54305-513
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	13.2 mg

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	24mm
Flavor	MENTHOL (Icy Menthol)	Imprint Code	R
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54305-513-10	10 in 1 PACKAGE; Type 0: Not a Combination Product	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/01/2020

Labeler - Ricola Ag (480227248)

Establishment
Name	Address	ID/FEI	Business Operations
Ricola Ag		485393768	manufacture(54305-513)