Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6f019744-35a4-487d-9c42-ccb6095d9b5d
Route
DENTAL
Published
Effective Date 2011-10-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.001 mL) Allantoin (0.0005 mL)
Inactive Ingredients
Alcohol Sodium Lauryl Sulfate Xylitol Saccharin Sodium Ginger Artemisia Princeps Leaf Cnidium Officinale Root Mint Methylparaben Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2011-10-04
Description

active ingredients: sodium fluoride, allantoin

Medication Information

Warnings and Precautions
store at room temperature

Indications and Usage
brush teeth with your tooth brush or gargle after spraying it into your mouth

Dosage and Administration
use when needed

dental use only

Description

active ingredients: sodium fluoride, allantoin

Section 50565-1
keep out of reach of the children

Section 51727-6
inactive ingredients: ethanol sodium lauryl sulfact, xylitol, sodium saccharin, ginger, mugwort extract, cnidium extract, mint, methylparaben, water

Section 51945-4
Section 55105-1
for dental care

Section 55106-9
active ingredients: sodium fluoride, allantoin

Structured Label Content

Indications and Usage (34067-9)
brush teeth with your tooth brush or gargle after spraying it into your mouth

Dosage and Administration (34068-7)
use when needed

dental use only

Warnings and Precautions (34071-1)
store at room temperature

Section 50565-1 (50565-1)
keep out of reach of the children

Section 51727-6 (51727-6)
inactive ingredients: ethanol sodium lauryl sulfact, xylitol, sodium saccharin, ginger, mugwort extract, cnidium extract, mint, methylparaben, water

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
for dental care

Section 55106-9 (55106-9)
active ingredients: sodium fluoride, allantoin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.022464 · Updated: 2026-03-14T22:52:53.430326