Label: GLOWING WHITE- sodium fluoride mouthwash
- NDC Code(s): 53942-435-45
- Packager: Demoulas Super Markets, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated April 21, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Use
- Warnings
- Keep out of reach of children.
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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
- Other information
- Disclaimer
- Adverse Reactions
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GLOWING WHITE
ANTICAVITY
MOUTHRINSE
Fresh Mint
Begins working on contact
5 days to whiter teeth
Helps strengthen teeth
Kills germs that cause bad breath
Sealed With Printed Neckband For Your Protection
IMPORTANT: read directions for proper use
32 FL OZ (946 mL)
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INGREDIENTS AND APPEARANCE
GLOWING WHITE
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53942-435 Route of Administration oral Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) HYDROGEN PEROXIDE (UNII: BBX060AN9V) POLOXAMER 407 (UNII: TUF2IVW3M2) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SUCRALOSE (UNII: 96K6UQ3ZD4) MENTHOL (UNII: L7T10EIP3A) PHOSPHORIC ACID (UNII: E4GA8884NN) SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53942-435-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 07/29/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 07/29/2015 Labeler - Demoulas Super Markets, Inc (007869647) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(53942-435) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(53942-435)