Label: RED CROSS TOOTHACHE- eugenol liquid
- NDC Code(s): 10742-0009-1
- Packager: The Mentholatum Company
- 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.
Drug Label Information
Updated February 7, 2023
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- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy alert: do not use if you are allergic to eugenol (clove oil)
When using this product
- use only in teeth with persistent, throbbing pain
- avoid touching tissues other than tooth cavity. Contact with lips or mucous membranes can cause burning, swelling, or irritation.
- DO NOT SWALLOW to avoid irritation
- do not use for more than 7 days
- do not exceed recommended dosage
- Keep Out of Reach of Children
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Directions
- rinse tooth with water to remove any food particles from the cavity
- using tweezers, immerse cotton pellet in medication
- to prevent dripping, squeeze gently between fingers to remove excess liquid
- place pellet in tooth cavity for one minutewithout touching surrounding tissues, then remove
- supervise children using this product
adults and children 12 years and over: use up to 4 times daily or as directed by a dentist or doctor
children under 12 years: ask a dentist or doctor
- Inactive Ingredients
- Questions
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INGREDIENTS AND APPEARANCE
RED CROSS TOOTHACHE
eugenol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-0009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL 850 mg in 1 mL Inactive Ingredients Ingredient Name Strength SESAME OIL (UNII: QX10HYY4QV) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10742-0009-1 1 in 1 BLISTER PACK 06/21/1983 1 3.7 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 06/21/1983 Labeler - The Mentholatum Company (002105757) Registrant - The Mentholatum Company (002105757) Establishment Name Address ID/FEI Business Operations The Mentholatum Company 002105757 manufacture(10742-0009)