Active Ingredient
Menthol 3.2%
Saint
FDA Label NDC 72784-101
12 label sections · Submitted to the FDA by Saint Medicine, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Saint Medicine, Inc. for the product Saint (NDC 72784-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, otc - keep out of reach of children, directions, when using this product, counsult a doctor when using:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough Suppressant
Use
To relieve cough, eliminate phlegm, anti-inflammatory, and relieve headache, sore throat, red eyes, throat and lung discomfort symptoms
Suitable for cough caused by the following diseases:
Cold, trachea and bronchitis, pulmonary fibrosis, pulmonary sarcoidosis
Warnings
For external use only
For nebulization inhalation only, do not take orally.
Please keep this product out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Keep Out Of Reach Of Children
Please keep this product out of the reach of children.
Directions
- see important warnings under "When using this product"
- adults & children 2 years & over:
- use 1 tablespoon of solution for each quart of water or 1½ teaspoonful of solution for each pint of water
- add solution directly to cold water only in a hot steam vaporizer (follow manufacturer's directions for using vaporizer)
- breathe in the medicated vapors
- use up to three times daily or as directed by a doctor
- children under 2 years: ask a doctor
When Using This Product
- Use as instructed.
- The persons with a history of allergies should try and observe.
Counsult A Doctor When Using:
- COPD, or a persistent chronic cough
- Asthma and emphsema patients
- Long-term smoking and coughing or cancer patients
- Patients with severe pulmonary heart disease
- Pregnant women, lactating women and children under the age of 12.
Usage
This product has been diluted and accurately dosed in accordance with FDA medication recommendations, 5 ml per vial, and it can be used by inhalation in an atomizer, each vial can be used once, 2-3 times a day.
Choose an atomizer and use it according to the manufacturer's instructions.
It is recommended to use mesh-sieve atomizer, medical-grade products should be selected, and that is product with medical device approval numbers.
Other Information:
The product should be stored strictly away from light and should be kept at low temperature.
The total amount is 15.22 ounces (150 ml), including 90 vials, 0.1691 ounces (5ml) per vial.
Inactive Ingredient
EGCG, Ginsenosides, N-Acetyl Cysteine, Nattokinase, Medical Purified Water
Principal Display Panel
72784-101-01
Pdp (72784 101 01)
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