Active Ingredient
Active Ingredient Purpose
Glycerin 7.5% v/v Oral Demulcent
Lemon Glycerin Swab
FDA Label NDC 67777-161
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Lemon Glycerin (NDC 67777-161). 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, use of lemon glycerin swabstick, warnings, keep out of reach of children, indications & usage, directions, other information, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Use Of Lemon Glycerin Swabstick
Use: Lemon_Glycerin
For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
Warnings
Warning:
For Oral Use Only.
- Do not get in eyes.
Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Indications & Usage
Indications and Usage
- For temporary relief of minor soreness and/or irritation of the mouth.
- Dry mouth relief.
Directions
Administration
- Swab mouth as needed.
- Discard after single use.
- Children under the age of 12 should be supervised in the use of this product.
- Children under 2 years of age consult a doctor.
Dosage
Other Information
Other information:
- Store at room temperature. 15 deg - 30 deg C, 58 deg - 86 deg F
- Avoid excessive heat.
Inactive Ingredients:
Inactive ingredients: Citric acid, lemon flavor, sodium benzoate, water
Principle Display Panel
Lemon Glycerin Swabstick
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