MARSHALL TOOTHACHE DROPS (eugenol 85%- clove oil 2% v/v solution/ drops

Marshall Toothache Drops by

Drug Labeling and Warnings

Marshall Toothache Drops by is a Otc medication manufactured, distributed, or labeled by Yashvire LLC, MARSHALLS TRADITIONAL HEALTHCARE CC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredient: Eugenol 85% (Clove Oil 2% v/v)

PURPOSE

Purpose: Surface Anaesthetic

INDICATIONS & USAGE

Uses: Acts as a surface anaesthetic temporarily relieving a toothache due to a cavity, until a dentist can be seen.

WARNINGS

Warnings:

For external use only.

Allergy alert: do not use if you are allergic to clove oil.

When using this product:

• Use only in teeth with persistent throbbing pain.
• Avoid touching tissues other than tooth cavity
• DO NOT SWALLOW to avoid irritation.
• Do not use for more than 48 hours.
• Do NOT use more than the recommended dose.

Stop use and ask a dentist or doctor if.

• irritation persists, inflammation develops, or if fever and infection develop.

See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions for Use:
Adults and Children over 12 years:

• Rinse tooth with water to remove any food particles from the cavity
• Apply 1-2 drops to a piece of cotton wool
• Swab affected area with the cotton wool or plug into affected cavity
• Leave in tooth cavity for 1 minute without touching surrounding tissues, then remove and discard.
• Discontinue use if irritation occurs. Avoid contact with cheek, gums, palate and lips
• Supervise children using this product

Use up to 4 times daily or as directed by a dentist or doctor.

OTHER SAFETY INFORMATION

Other information. Do not purchase if package has been opened.

Store at 46 – 90 F. (8 – 32 oC). Cap tightly to avoid evaporation.

INACTIVE INGREDIENT

Inactive ingredients: Ethyl alcohol, Purified water, Carmoisine red dye

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC: 74094-002-01 - Carton

Marshall Toothache Drops - 10 ml (0.33 fl.oz) - NDC: 74094-002-01 - Container

INGREDIENTS AND APPEARANCE

MARSHALL TOOTHACHE DROPS 
eugenol 85% (clove oil 2% v/v) solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74094-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW)	EUGENOL	17 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	529 mg  in 1 mL
WATER (UNII: 059QF0KO0R)	310 mg  in 1 mL
CARMOISINE (UNII: DR4641L47F)	0.1 mg  in 1 mL

Product Characteristics
Color	red (Clear red liquid with odour of clove oil)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74094-002-01	1 in 1 CARTON	05/17/2021
1		10 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 not final	part356	05/17/2021

Labeler - Yashvire LLC (117396744)

Registrant - MARSHALLS TRADITIONAL HEALTHCARE CC (637662219)

Establishment
Name	Address	ID/FEI	Business Operations
MARSHALLS TRADITIONAL HEALTHCARE CC		637662219	manufacture(74094-002) , pack(74094-002) , label(74094-002)