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Drug Facts
DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716
PRODUCT OF CANADA
Equate Anticavity Oral Rinse
FDA Label NDC 49035-535
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wal-mart Stores, Inc. for the product Equate Anticavity Oral Rinse (NDC 49035-535). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Sodium fluoride 0.021%
(0.01% w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Use aids in the prevention of dental cavities
Warnings
Warnings
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Adults and children 6 years and older: use twice a day after brushing your teeth with a toothpaste
- vigorously swish 10 mL (2 teaspoonfuls) 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
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise childrenas necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Inactive Ingredient
Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, red 33, green3
Otc - Questions
Questions? Call 1-888-287-1915
Package Label.Principal Display Panel
equate™
Anticavity Oral Rinse
Multi-Action with Fluoride
33.8 FL OZ (1L)
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