Kroger 482.002/482ac

Kroger 482.002/482ac
SPL v15
SPL
SPL Set ID 5459eeee-adf0-4afe-b190-62d4fa113806
Route
ORAL
Published
Effective Date 2025-01-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Cetylpyridinium Chloride Cinnamaldehyde Saccharin Sodium Phosphoric Acid Sodium Benzoate Sucralose Poloxamer 407 Benzoic Acid Sodium Phosphate, Dibasic, Anhydrous Propylene Glycol D&c Red No. 33 Fd&c Green No. 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-07

Description

Kroger  ® ENAMEL DEFEND ANTICAVITY FLUORIDE RINSE

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Kroger  ® ENAMEL DEFEND ANTICAVITY FLUORIDE RINSE

Use

aids in the prevention of dental cavities

Claims

Kroger  ®

ENAMEL DEFEND

ANTICAVITY FLUORIDE RINSE

Warning

For this product

Directions

Adults and children 6 years of age and older:

  • use twice daily 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 without supervision
  • children under 6 years of age: consult a dentist or doctor
Adverse Reaction

THIS RINSE MAY CAUSE TEMPORARY STAINING TO THE SURFACE OF TEETH. 

THIS IS NOT HARMFUL, AND ADEQUATE BRUSHING MAY PREVENT ITS OCCURRENCE.

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY PROCTER & GAMBLE, DISTRIBUTOR OF CREST ® PRO-HEALTH ® ADVANCED ANITCAVITY FLUORIDE MOUTHWASH ENAMEL CARE ALCOHOL FREE.

**THIS PRODUCT IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING.

PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

QUALITY GUARANTEED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

Active Ingredient

Sodium fluoride 0.02%

(0.01% w/v fluoride ion)

Inactive Ingredients

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Questions Or Comments?

1-800-632-6900

Principal Display Panel

MULTI-ACTION WITH FLUORIDE

COMPARE TO CREST  ®PRO-HEALTH  ®ADVANCED ENAMEL CARE MOUTHWASH

*SEE BACK LABEL

Kroger  ®

ENAMEL DEFEND

ANTICAVITY FLUORIDE RINSE

ALCOHOL-FREE

VIVID MINT

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

HELPS PREVENT CAVITIES

CLEANS TEETH**

FRESHENS BREATH

HELPS STRENGTHEN ENAMEL

KILLS BAD BREATH GERMS

QUALITY GUARANTEED

33.8 FL OZ (1.05 QT) 1L

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.


Structured Label Content

Use (use)

aids in the prevention of dental cavities

Claims

Kroger  ®

ENAMEL DEFEND

ANTICAVITY FLUORIDE RINSE

Purpose

Anticavity

Warning

For this product

Directions

Adults and children 6 years of age and older:

  • use twice daily 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 without supervision
  • children under 6 years of age: consult a dentist or doctor
Adverse Reaction (ADVERSE REACTION)

THIS RINSE MAY CAUSE TEMPORARY STAINING TO THE SURFACE OF TEETH. 

THIS IS NOT HARMFUL, AND ADEQUATE BRUSHING MAY PREVENT ITS OCCURRENCE.

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY PROCTER & GAMBLE, DISTRIBUTOR OF CREST ® PRO-HEALTH ® ADVANCED ANITCAVITY FLUORIDE MOUTHWASH ENAMEL CARE ALCOHOL FREE.

**THIS PRODUCT IS NOT INTENDED TO REPLACE BRUSHING OR FLOSSING.

PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

QUALITY GUARANTEED

Quality Guaranteed

Kroger.com/guarantee

800-632-6900

Active Ingredient (Active ingredient)

Sodium fluoride 0.02%

(0.01% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetylpyridinium chloride, flavor, cinnamal, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, red 33, green 3

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel (principal display panel)

MULTI-ACTION WITH FLUORIDE

COMPARE TO CREST  ®PRO-HEALTH  ®ADVANCED ENAMEL CARE MOUTHWASH

*SEE BACK LABEL

Kroger  ®

ENAMEL DEFEND

ANTICAVITY FLUORIDE RINSE

ALCOHOL-FREE

VIVID MINT

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

HELPS PREVENT CAVITIES

CLEANS TEETH**

FRESHENS BREATH

HELPS STRENGTHEN ENAMEL

KILLS BAD BREATH GERMS

QUALITY GUARANTEED

33.8 FL OZ (1.05 QT) 1L

Keep Out of Reach of Children (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.


Advanced Ingredient Data


Raw Label Data

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