SPL v2
SPL
SPL Set ID 38ddf1a7-29ab-cb8d-e063-6294a90ad34c
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.85 mg) Glycerin (100 mg)
Inactive Ingredients
Aloe Aqua Sodium Benzoate Xylitol Menthol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01
Description

Aqua, Xylitol, Aloe, Glycerin, Menthol, Sodium Benzoate, Citric acid

Medication Information

Warnings and Precautions

Warnings:

For oral use only.Do not swallow. Not for children under 6 years of age Stop use and

ask a doctor if irritation or discomfort occurs. Keep out of reach of children

Indications and Usage

Usage:

For temporary relief of dry mouth

Helps kill germs that cause bad breath

Helps reduce plaque that leads to early gum problems

Freshens breath

Dosage and Administration

Description

Aqua, Xylitol, Aloe, Glycerin, Menthol, Sodium Benzoate, Citric acid

Section 50565-1

Warnings: For oral use only.Do not swallow. Not for children under 6 years of age Stop use and

ask a doctor if irritation or discomfort occurs. Keep out of reach of children

Section 51727-6

Aqua, Xylitol, Aloe, Glycerin, Menthol, Sodium Benzoate, Citric acid

Section 51945-4

Section 55105-1

Purpose:

Glycerin – Temporarily relieves dry mouth

-Cetylpyridinium Chloride – Helps reduce germs that cause bad breath and plaque

Structured Label Content

Indications and Usage (34067-9)

Usage:

For temporary relief of dry mouth

Helps kill germs that cause bad breath

Helps reduce plaque that leads to early gum problems

Freshens breath

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Warnings:

For oral use only.Do not swallow. Not for children under 6 years of age Stop use and

ask a doctor if irritation or discomfort occurs. Keep out of reach of children

Section 50565-1 (50565-1)

Warnings: For oral use only.Do not swallow. Not for children under 6 years of age Stop use and

ask a doctor if irritation or discomfort occurs. Keep out of reach of children

Section 51727-6 (51727-6)

Aqua, Xylitol, Aloe, Glycerin, Menthol, Sodium Benzoate, Citric acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose:

Glycerin – Temporarily relieves dry mouth

-Cetylpyridinium Chloride – Helps reduce germs that cause bad breath and plaque

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:39.808058 · Updated: 2026-03-14T23:09:33.254922