Label: MARSHALL TOOTHACHE DROPS (eugenol 85%- clove oil 2% v/v solution/ drops
- NDC Code(s): 74094-002-01
- Packager: Yashvire LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated May 18, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
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
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
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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)