Tamper Evident Statement
Sealed with printed neckband for your protection
Anticavity Rinse Mouthwash
FDA Label NDC 49035-004
12 label sections · Submitted to the FDA by Walmart Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walmart Inc. for the product Anticavity Rinse (NDC 49035-004). 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 tamper evident statement, active ingredient, purpose, use, warnings, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium Fluoride 0.05% (0.2% w/v fluoride ion)
Purpose
Anticavity
Use
aids in the prevention of dental cavities
Warnings
for this product
Keep Out Of Reach Of Children.
If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.
Directions
Adults and children 6 year of age and older:
- use once 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
- instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
- supervise children as necessary until capable of using without supervision
Children under 6 year of age: consult a dentist or doctor
Other Information
- store at room temperature
Inactive Ingredients
benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxomer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water
Adverse Reaction
Distributed by: Walmart Inc.,
Bentonville, AR 72716
Satisfaction guaranteed - for questions or comments please call 1-888-287-1915
Disclaimer
Made in the USA
with domestic and imported ingredients
Factory Certified
*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademarks ACT® {and} Bubblegum Blow Out® Anticavity Kids Fluoride Rinse.
Discard Empty & Replace Cap
PLASTIC BOTTLE
how2recycle.info
Principal Display Panel
NDC: 49035-004-44
KIDS
equate™
Compare to ACT ® Bubblegum Blowout ® Anticavity Kids Fluoride Rinse active ingredient*
BUBBLE GUM FLAVOR
Kids Anticavity Fluoride Rinse
Strong cavity protection
Helps strengthen teeth
ADA Accepted
American Dental Assoication
- Helps prevent cavities
ALCOHOL FREE
IMPORTANT: Read directions for proper use.
18 FL OZ (1.12 PT) 532 mL
Image Description (Mm01)
Image Description (Mm02)
* Please review the disclaimer below.
