FDA Label for Marshall Toothache Drops
View Indications, Usage & Precautions
Marshall Toothache Drops Product Label
The following document was submitted to the FDA by the labeler of this product Yashvire Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Drug Facts
Active Ingredient: Eugenol 85% (Clove Oil 2% v/v)
Otc - 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.
- irritation persists, inflammation develops, or if fever and infection develop.
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.
Otc - 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
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