Label: ORAL ANTIVAVITY- sodium fluoride mouthwash
- NDC Code(s): 30142-576-86
- Packager: Kroger Co
- 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
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- Official Label (Printer Friendly)
- claims
- Active ingredient
- Purpose
- 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 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 witout supervision
- children under 6 years of age: consult a dentist or doctor
- Inactive ingredients
- Questions or comments?
- Claims
- Disclaimer
- Adverse Reactions
-
principal display panel
COMPARE TO
the active ingredient of
CREST PRO-HEALTH COMPLETE
ANTICAVITY FLUORIDE RINSE
See Back Label
Kroger
Refreshing Mint
ALCOHOL-FREE
FLUORIDE MOUTHWASH
ANTICAVITY FLUORIDE RINSE
IMPORTANT: read directions for proper use.
- Helps Prevent Cavities
- Helps Make Enamel Stronger
- Helps Clean the Entire Mouth
- Helps Kill Germs that Cause Bad Breath
- Helps Freshen Breath
- No Alcohol Burn
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
33.8 FL OZ (1 L)
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INGREDIENTS AND APPEARANCE
ORAL ANTIVAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-576 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 10.41 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) POLOXAMER 407 (UNII: TUF2IVW3M2) PHOSPHORIC ACID (UNII: E4GA8884NN) METHYLPARABEN (UNII: A2I8C7HI9T) SACCHARIN SODIUM (UNII: SB8ZUX40TY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-576-86 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/06/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 02/06/2015 Labeler - Kroger Co (006999528) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(30142-576) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(30142-576)