Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc

Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
SPL v5
SPL
SPL Set ID f7edf75c-cdba-4dde-bfc5-a04af34759d3
Route
ORAL
Published
Effective Date 2025-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Eucalyptol (0.92 mg) Menthol (0.42 mg) Salicylic Acid (0.6 mg) Thymol (0.64 mg)
Inactive Ingredients
Water Alcohol Sorbitol Poloxamer 407 Sodium Benzoate Benzoic Acid Sucralose Saccharin Sodium Zinc Chloride Green 3

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)

Purpose

Antiplaque/antigingivitis


Medication Information

Purpose

Antiplaque/antigingivitis

Description

Eucalyptol (0.092%) Menthol (0.042%) Methyl Salicylate (0.060%) Thymol (0.064%)

 

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Uses

helps prevent and reduce

  • plaque
  • gingivitis
Purposes

Antiplaque/antigingivitis

Directions
  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Do Not Use

in children under 12 years of age.

Package Label
FAMILY WELLNESS Blue Mint Tartar Control Mouthwash
Active Ingredient

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl Salicylate (0.060%)

Thymol (0.064%)

Other Information
  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

water, alcohol (21.6% v/v), sorbitol, poloxamer 407, flavor, sodium benzoate, benzoic acid, sucralose, sodium saccharin, zinc chloride, flavor, FD&C green #3

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE® ULTRACLEAN® COOL MINT®*

BLUE MINT

TARTAR CONTROL

MOUTHWASH

Antigingivitis/Antiplaque Mouthwash

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

  • Kills germs that cause plaque, gingivitis, bad breath
  • Helps to control and prevent plaque that leads to gingivitis
  • Controls tartar that can discolor teeth
  • Fresh breath and mouth cooling sensation

L (qt fl oz)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine® Ultraclean® Cool Mint®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320 

Stop Use and Ask A Dentist
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing 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 (1-800-222-1222) right away


Structured Label Content

 

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Uses

helps prevent and reduce

  • plaque
  • gingivitis
Purposes

Antiplaque/antigingivitis

Directions
  • adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
  • children 6 years to under 12 years of age: supervise use
  • children under 6 years of age: do not use
Do Not Use (Do not use)

in children under 12 years of age.

Package Label (Package label)
FAMILY WELLNESS Blue Mint Tartar Control Mouthwash
Active Ingredient (Active ingredient)

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl Salicylate (0.060%)

Thymol (0.064%)

Other Information (Other information)
  • store at room temperature
  • cold weather may cloud this product. Its antiseptic properties are not affected.
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients (Inactive ingredients)

water, alcohol (21.6% v/v), sorbitol, poloxamer 407, flavor, sodium benzoate, benzoic acid, sucralose, sodium saccharin, zinc chloride, flavor, FD&C green #3

Principal Display Panel (Principal display panel)

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE® ULTRACLEAN® COOL MINT®*

BLUE MINT

TARTAR CONTROL

MOUTHWASH

Antigingivitis/Antiplaque Mouthwash

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

  • Kills germs that cause plaque, gingivitis, bad breath
  • Helps to control and prevent plaque that leads to gingivitis
  • Controls tartar that can discolor teeth
  • Fresh breath and mouth cooling sensation

L (qt fl oz)

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Listerine® Ultraclean® Cool Mint®.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320 

Stop Use and Ask A Dentist (Stop use and ask a dentist)
  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing 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 (1-800-222-1222) right away


Advanced Ingredient Data


Raw Label Data

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