Claims
dentalux
REFRESHING MINT
MULTI-ACTION
Sodium Fluoride Mouthwash
FDA Label NDC 71141-576
13 label sections · Submitted to the FDA by Lidl Us, Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lidl Us, Llc for the product Sodium Fluoride (NDC 71141-576). 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 claims, active ingredient, purpose, use, warnings, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Sodium fluoride 0.02% (0.01% 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, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 6 years of age 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 children as necessary until capable of using without supervision
- children under 6 years of age: consult a dentist or doctor
Inactive Ingredients
water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1
Questions?
Call 1-844-344-5071
Disclaimers
This rinse may cause temporary staining to the surface of teeth.
This is not harmful, and adequate brushing may prevent its occurrence.
*This product is not manufactured or distributed by Procter and Gamble, distributor of Crest ® Pro-Health ® Advanced Anticavity Fluoride Mouthwash Multi-Protection Alcohol Free.
Adverse Reactions
DISTRIBUTED BY LIDL US, LLC
3500 S. CLARK STREET, ARLINGTON, VA 22202
QUESTIONS? 1-844-344-5071 WWW.LIDL.COM
Lidl
PLASTIC BOTTLE
Widely Recyclable
Discard Seal, Empty & Replace Cap
how2recycle.info
Tamper Evident Statement
DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.
Principal Display Panel
ALCOHOL FREE
dentalux
REFRESHING MINT
MULTI-ACTION
ANTICAVITY FLUORIDE MOUTHWASH
- Helps strengthen enamel
- Helps clean the entire mouth
- Helps prevent cavities
- Freshens breath
- Kills bad breath germs
- Helps keep mouth feeling clean
COMPARE TO Crest ® Pro-Health ® Advanced Alcohol Free MOUTHWASH*
IMPORTANT: READ DIRECTIONS FOR PROPER USE.
33.8 FL OZ (1.05 QT) 1 L
Mm01 (Mm01)
Mm02 (Mm02)
* Please review the disclaimer below.
