ANTICAVITY- sodium fluoride rinse

Anticavity by

Drug Labeling and Warnings

Anticavity by is a Otc medication manufactured, distributed, or labeled by H E Butt, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity 

Use

aids in the prevention of dental cavities

Warning

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 daily after brushing your teeth with a toothpaste
• vigorously swish 10 mL 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

Other information

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

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, Mentha viridis (spearmint) leaf oil, Mentha piperita (peppermint) oil, red 40, blue 1

Questions?

Call 1-888-593-0593

Disclaimers

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Listerine ® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash.

**This product is not intended to replace brushing or flossing.

Adverse reactions section

MADE WITH PRIDE AND CARE FOR H-E-B ®

SAN ANTONIO, TX 78204

100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.

You have our word on it.

US ONLY

PLASTIC BOTTLE

Widely Recyclable

Discard Seal, Empty & Replace Cap

how2recycle.info

principal display panel

Compare to Listerine ® Total Care Zero Alcohol Anticavity Fresh Mint Mouthwash*

H-E-B ®

COMPLETE ACTION

ANTICAVITY MOUTHWASH SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPCAL SOLUTION

CLEANS THE ENTIRE MOUTH**

ALCOHOL FREE

Helps Prevent Cavities

Restores Enamel

FRESH MINT

IMPORTANT: read directions for proper use

33.8 FL OZ (1.05 QT) 1 L

INGREDIENTS AND APPEARANCE

ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-119
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHOSPHORIC ACID (UNII: E4GA8884NN)
EUCALYPTOL (UNII: RV6J6604TK)
METHYL SALICYLATE (UNII: LAV5U5022Y)
THYMOL (UNII: 3J50XA376E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL (UNII: L7T10EIP3A)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SPEARMINT OIL (UNII: C3M81465G5)
PEPPERMINT OIL (UNII: AV092KU4JH)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37808-119-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	04/20/2021

Labeler - H E B (007924756)

Registrant - Nice-Pak Products, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Nice-Pak Products, LLC		119091514	manufacture(37808-119)