Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc

Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
SPL v8
SPL
SPL Set ID 9f991292-bbaa-4f4e-b2cb-059d1a04849e
Route
ORAL
Published
Effective Date 2025-10-31
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 Poloxamer 407 Benzoic Acid Sodium Benzoate Caramel

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01
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%)

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 Antiseptic 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 
Inactive Ingredients

water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel

Questions Or Comments

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

Principal Display Panel

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE®*

ORIGINAL

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque Mouthwash

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

  • Kill germs that cause plaque, gingivitis, bad breath
  • Helps to control and prevent plaque that leads to gingivitis

mL (fl oz)

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

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320 

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 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

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 Antiseptic 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 
Inactive Ingredients (Inactive ingredients)

water, alcohol (26.9% v/v), poloxamer 407, sodium benzoate, benzoic acid, caramel

Questions Or Comments (Questions or comments)

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

Principal Display Panel (Principal display panel)

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE®*

ORIGINAL

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque Mouthwash

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

  • Kill germs that cause plaque, gingivitis, bad breath
  • Helps to control and prevent plaque that leads to gingivitis

mL (fl oz)

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

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

510 VOLVO PKWY, CHESAPEAKE, VA 23320 

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 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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:27.688605 · Updated: 2026-03-14T23:13:18.140905