Eucalyptol

FDA Drug Profile — Antiseptic Mouth Rinse

Drug Details

Generic Name
Eucalyptol
Brand Names
Antiseptic Mouth Rinse
Application Number
505G(a)(3)
Sponsor
Jindal Drugs Private Limited
NDC Codes
2
Dosage Forms
OIL, MOUTHWASH
Routes
ORAL
Active Ingredients
EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL

Indications and Usage

INDICATIONS: Aids in temporary relief of headaches, runny nose, chills, minor cough, fatigue, and mild abdominal discomfort.† †Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings

WARNINGS: Professional Use Only If pregnant or breast-feeding, ask a health professional before use. In case of overdose, get medical help or contact a Poison Control Center right away. If condition worsens, seek medical attention. KEEP OUT OF REACH OF CHILDREN Do not use if tamper evident seal is broken or missing. Store in a cool place after opening