Active Ingredient
Glycerin 7.5% v/v
Lemon Glycerine Swab
FDA Label NDC 60913-061
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Phoenix Healthcare Solutions, Llc for the product Lemon Glycerine (NDC 60913-061). 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, uses, warnings, do not use, keep out of reach of children, directions:, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Oral Demulcent
Uses
- For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
- Dry mouth relief.
Warnings
For Oral Use Only.
Do Not Use
Do not get in eyes
Keep Out Of Reach Of Children
Keep out of reach of children
Directions:
- 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.
Other Information
- Store at room temperature: 15 C - 30 C
- Avoid excessive heat
Inactive Ingredients:
Citric acid, lemon flavor, sodium benzoate, water
Principal Display Panel
NDC 60913-061-01
Phoenix Healthcare Solutions LLC
"An Innovative Medical Manufacturer"
Lemon-Glycerine Swabsticks
For Professional and Hospital Use
Antiseptic/Germicide
50 Pouches Per Box
1 Swabstick Per Pouch
Label (01)
NDC 60913-061-03
Phoenix Healthcare Solutions LLC
"An Innovative Medical Manufacturer"
Lemon-Glycerine Swabsticks
For Professional and Hospital Use
Antiseptic/Germicide
25 Pouches Per Box
3 Swabstick Per Pouch
Label (03)
* Please review the disclaimer below.
