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

Drug Facts

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

Purpose: Surface Anaesthetic

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

Warnings:

For external use only.

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

When using this product:

Stop use and ask a dentist or doctor if.

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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions for Use:
Adults and Children over 12 years:

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

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

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

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 - Carton

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

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

MARSHALL TOOTHACHE DROPS 
eugenol 85% (clove oil 2% v/v) solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74094-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL17 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
Colorred (Clear red liquid with odour of clove oil) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74094-002-011 in 1 CARTON05/17/2021
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/17/2021
Labeler - Yashvire LLC (117396744)
Registrant - MARSHALLS TRADITIONAL HEALTHCARE CC (637662219)
Establishment
NameAddressID/FEIBusiness Operations
MARSHALLS TRADITIONAL HEALTHCARE CC637662219manufacture(74094-002) , pack(74094-002) , label(74094-002)

Revised: 5/2021
Document Id: c29b982b-6f03-6e08-e053-2995a90a58c1
Set id: 824d2f95-bfb8-4d20-8aec-ec4ec4841c7d
Version: 1
Effective Time: 20210518
 
Yashvire LLC