TheraBreath Anticavity
TheraBreath Anticavity
3c5d58f1-ea8c-4708-bbc6-21e1cd1446da
HUMAN OTC DRUG LABEL
Sep 19, 2025
Church & Dwight Co., Inc.
DUNS: 001211952
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (14)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 1 L Bottle Label
ANTICAVITY FLUORIDE RINSE
USE 2X
DAILY
TheraBreath ™
DENTIST FORMULATED
ANTICAVITY
ORAL RINSE
HELPS FIGHT CAVITIES FOR 24 HOURS*
STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH
Helps rebuild weakened tooth enamel and prevent tooth decay
No Alcohol • With Fluoride • Non-Burning
Sodium Fluoride 0.02%
IMPORTANT:
Read directions for proper use.
33.8 FL OZ
(1.05 QT) 1 L
SPARKLE MINT
INDICATIONS & USAGE SECTION
Use
aids in the prevention of dental cavities
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium fluoride 0.02% (0.01% w/v fluoride ion)
WARNINGS SECTION
Warning
Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
Adults 18 years of age and older:
- use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
- do not swallow the rinse
- do not eat or drink for 30 minutes after rinsing
STORAGE AND HANDLING SECTION
Other information
- do not use if safety seal is broken or missing
OTC - PURPOSE SECTION
Purpose
Anticavity
INACTIVE INGREDIENT SECTION
Inactive ingredients
water, glycerin, PEG-40 hydrogenated castor oil, citric acid, sodium hydroxide, sodium chlorite, menthol, citrus lemon peel oil, Mentha piperita oil, sodium benzoate, sucralose, xylitol, sodium bicarbonate