kroger d53.000/d53aa

kroger d53.000/d53aa
SPL v4
SPL
SPL Set ID 0e61d4a1-0b81-4bca-bdb3-b9927278b769
Route
oral
Published
Effective Date 2025-06-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.5 mg)
Inactive Ingredients
water alcohol propylene glycol poloxamer 407 sucralose benzoic acid sodium benzoate cinnamaldehyde fd&c blue no. 1 fd&c yellow no. 6

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-13

Purpose

Antigingivitis, Antiplaque

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Medication Information

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Other Information
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

Description

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Use

helps control plaque that leads to gingivitis

Claims

Kroger ®

INTENSE

ANTIGINGIVITIS

ANTIPLAQUE

MOUTHWASH

Disclaimers

This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*CREST ® AND PRO-HEALTH ®ARE REGISTERED TRADEMARKS OF PROCTER & GAMBLE.

Adverse Reaction

PROUDLY DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

QUALITY GUARANTEED

Kroger.com/guarantee

800-632-6900

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

DSP-TN-21091 DSP-MO-20087

Active Ingredient

Cetylpyridinium Chloride 0.05%

Questions Or Comments?

Call 1-800-632-6900

Principal Panel Display

COMPARE TO the active ingredient in CREST ® PRO-HEALTH ® INTENSE CLEAN MINT MOUTHWASH

*See Back Label

Kroger ®

INTENSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

COOLING SENSATION

POWERFUL FRESH MINT

KILLS 99% OF GERMS†

FRESHENS BREATH

HELPS KEEP TEETH CLEAN

PARABEN-FREE

COOLING

HELPS PREVENT PLAQUE & GINGIVITIS 

SUGAR FREE

†Kills at least 99% of many organisms commonly assoicated with bad breath in as little as 15 seconds

QUALITY GUARANTEED

33.8 FL OZ  (1.5 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

for this product

Purpose

Antigingivitis, Antiplaque

Directions
  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
  • when used after brushing, rinse mouth with water first
  • children under 6 years of age: do not use
Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients (Inactive ingredients)

water, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, cinnamal, blue 1, yellow 6

Use

helps control plaque that leads to gingivitis

Claims

Kroger ®

INTENSE

ANTIGINGIVITIS

ANTIPLAQUE

MOUTHWASH

Disclaimers

This may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.

*CREST ® AND PRO-HEALTH ®ARE REGISTERED TRADEMARKS OF PROCTER & GAMBLE.

Adverse Reaction

PROUDLY DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

MADE IN USA WITH DOMESTIC AND FOREIGN COMPONENTS

QUALITY GUARANTEED

Kroger.com/guarantee

800-632-6900

FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900

DSP-TN-21091 DSP-MO-20087

Active Ingredient

Cetylpyridinium Chloride 0.05%

Questions Or Comments? (Questions or Comments?)

Call 1-800-632-6900

Principal Panel Display

COMPARE TO the active ingredient in CREST ® PRO-HEALTH ® INTENSE CLEAN MINT MOUTHWASH

*See Back Label

Kroger ®

INTENSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

COOLING SENSATION

POWERFUL FRESH MINT

KILLS 99% OF GERMS†

FRESHENS BREATH

HELPS KEEP TEETH CLEAN

PARABEN-FREE

COOLING

HELPS PREVENT PLAQUE & GINGIVITIS 

SUGAR FREE

†Kills at least 99% of many organisms commonly assoicated with bad breath in as little as 15 seconds

QUALITY GUARANTEED

33.8 FL OZ  (1.5 QT) 1 L

Tamper Evident Statement

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Stop Use and Ask A Dentist If (Stop use and ask a dentist if)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep Out of Reach of Children Under 6 Years of Age. (Keep out of reach of children under 6 years of age.)

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


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