Active Ingredient
Glycerin 7.5% v/v
Lemon Swab
FDA Label NDC 68786-160
9 label sections · Submitted to the FDA by Sion Biotext Medical Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sion Biotext Medical Ltd for the product Lemon (NDC 68786-160). 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, warning:, otc - keep out of reach of children, use, 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
Purpose
Oral Demulcent
Warning:
For Oral Use Only.
- Do not get in eyes.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Use
- For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat.
- Dry mouth relief.
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 (59°F - 86 °F)
- Avoid excessive heat.
Inactive Ingredients
Citric acid, lemon flavor, sodium benzoate, water
Principle Display Panel
25 packets
3 swabsticks per packet
Lemon-Glycerin Swabstick
For Professional and Hospital Use
Sion Biotext Medical Ltd
68786-160-02
Label (02)
50 packets
1 swabstick per packet
Lemon-Glycerin Swabstick
For Professional and Hospital Use
Sion Biotext Medical Ltd
68786-160-01
Label (01)
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