Cavity Protection Fresh Mint Anticavity Mouthwash

SPL v4

SPL

SPL Set ID 3efc66b2-fcf9-4d26-9cdd-1af8225312b4

Route

ORAL

Published

Effective Date 2022-05-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.5 mg)

Inactive Ingredients

Chlorine Dioxide Water Xylitol Sodium Benzoate Potassium Phosphate, Unspecified Form Oxygen Sodium Hydroxide Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-05-23 Until 2026-01-31

Description

Sodium fluoride 0.05%

Purpose

Anticavity rinse

Medication Information

Purpose

Anticavity rinse

Description

Sodium fluoride 0.05%

Uses

Helps protect against cavities.

Warnings

For rinsing only. Do not swallow.

Directions

Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

Do Not Use

if safety seal is torn or missing.

Drug Facts

Ingredients

Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid.

*Contains Peppermint Essential Oil

Active Ingredient

Sodium fluoride 0.05%

Other Information

Store away from direct sunlight.

Package Labeling:3.8 L

Package Labeling:473ml

Keep Out of Reach of Children

under six years of age.

Not to be used by children under six, unless recommended by a dentist or physician.
If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.

Structured Label Content

Uses

Helps protect against cavities.

Purpose

Anticavity rinse

Warnings

For rinsing only. Do not swallow.

Directions

Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.

Do Not Use (Do not use)

if safety seal is torn or missing.

Drug Facts

Ingredients (INGREDIENTs)

Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid.

*Contains Peppermint Essential Oil

Active Ingredient (Active ingredient)

Sodium fluoride 0.05%

Other Information (Other information)

Store away from direct sunlight.

Package Labeling:3.8 L

Package Labeling:473ml

Keep Out of Reach of Children (Keep out of reach of children)

under six years of age.

Not to be used by children under six, unless recommended by a dentist or physician.
If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away.

Advanced Ingredient Data

[{"name": "CHLORINE DIOXIDE", "unii": "8061YMS4RM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM PHOSPHATE, UNSPECIFIED FORM", "unii": "B7862WZ632", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OXYGEN", "unii": "S88TT14065", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps protect against cavities.", "Purpose": "Anticavity rinse", "Warnings": "For rinsing only. Do not swallow. ", "Directions": "Shake well before using. Vigorously swish 1-2 capfuls for a minimum of 1 full minute. Refrain from rinsing, eating or drinking for 5 minutes.", "Do not use": "if safety seal is torn or missing.", "INGREDIENTs": "Water (Aqua), Xylitol, Sodium Benzoate, Potassium Phosphate, Flavor*, Stabilized Chlorine Dioxide (Oxygene), Sodium Hydroxide, Citric Acid. *Contains Peppermint Essential Oil", "Active ingredient": "Sodium fluoride 0.05%", "Other information": "Store away from direct sunlight.", "Keep out of reach of children": "under six years of age. Not to be used by children under six, unless recommended by a dentist or physician. If more than one ounce is accidentally swallowed, contact a physician or Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:59.163213 · Updated: 2026-03-14T23:10:07.372921