Label: ANTICAVITY- sodium fluoride mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 30142-435-45 - 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 February 22, 2016
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
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OTHER SAFETY INFORMATION
Contains peroxide which releases oxygen while whitening. This may cause the bottle to inflate slightly or release air when opened.
*Listerine is a registered trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903. Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.
DISTRIBUTED BY
The Kroger Co.
Cincinnatti, OH 45202
800-632-6900 www.kroger.com
DSP-TN-15000
DSP-MO-34
SDS-TN-15012
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PRINCIPAL DISPLAY PANEL
Compare to the ingrdients of Listerine Healthy White Vibrant Anticavity Mouthrinse *See back label
Fresh Mint
Whitening Anticavity Mouthrinse
Safely whitens teeth
Kills germs that cause bad breath
Helps strengthen teeth
Sealed with printed neckband for your protection
IMPORTANT: Read directions for proper use
946 mL (32 FL OZ)
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INGREDIENTS AND APPEARANCE
ANTICAVITY
sodium fluoride mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-435 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, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-435-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 09/15/2015 Labeler - Kroger Co (006999528) Registrant - Vi-Jon, Inc. (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, Inc. 790752542 manufacture(30142-435)