Anticavity Fluoride Rinse: Package Insert and Label Information

ANTICAVITY FLUORIDE RINSE- sodium fluoride mouthwash
Midwood Brands, Inc

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.

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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 12 years of age and older:

  • use twice daily after brushing your teeth with 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
  • supervise children as necessary until capable of using without supervision
  • children under 12 years of age: consult a dentist or doctor

Other information

  • store at controlled room temperature 20⁰ -25⁰ C (68⁰ — 77⁰ F)
  • cold weather may temporarily cloud this product

Inactive ingredients

water, alcohol (21.6%), sorbitol, poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphori acid, sucralose, menthol, disosium phosphate, red 40, blue 1

Disclaimer

This product is not manufacturd or distributed by Johnson + Johnson Healthcare Products, owner of the registered trademark Listerine*

DISTRIBUTED BY:
Midwood Brands, Inc
10401 MONROE RD
MATTHEWS, NC 28105

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

FAMILY WELLNESS

COMPARE TO THE ACTIVE INGREDIENT OF LISTERINE TOTAL CARE ANTICAVITY MOUTHWASH

Anticavity Fluoride Mouthwash

Sodium Fluoride and Acidulated Phosphate Topical Solution

Helps Prevent Cavities

Strengthen Teeth and Kill Germs That Cause Bad Breath

Cleans Entire Mouth and Freshens Breath

Restores Enamel

EUCALYPTUS MINT

IMPORTANT: READ DIRECTIONS FOR PROPER USE

1 L (33.8 FL OZ)

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ANTICAVITY FLUORIDE RINSE
sodium fluoride mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
water
ALCOHOL
SORBITOL
POLOXAMER 407
SODIUM LAURYL SULFATE
EUCALYPTOL
METHYL SALICYLATE
THYMOL
PHOSPHORIC ACID
sucralose
MENTHOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C RED NO. 40
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55319-163-86 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 12/14/2011
Labeler — Midwood Brands, Inc (024472631)
Registrant — Vi Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon, LLC 790752542 manufacture (55319-163)

Revised: 08/2021 Midwood Brands, Inc

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