Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc

Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
SPL v4
SPL
SPL Set ID 9a9c5c6b-94fe-484a-a879-12c29cbdefe4
Route
ORAL
Published
Effective Date 2025-07-11
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 Saccharin Sodium Fd&c Green No. 3 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-12-30

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
EQUATE Antiseptic Mouthwash Green Mint
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, sodium benzoate, benzoic acid, sodium saccharin, flavor, D&C yellow #10, FD&C green #3

Questions Or Comments

1-888-287-1915

Principal Display Panel

Compare to Listerine® Freshburst® active ingredients*

Antiseptic Mouthwash

Green Mint

Kills germs that cause plaque, gingivitis bad breath

Help to control and prevent plaque that leads to gingivitis

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

Antiplaque/antigingivitis

L (QT PT FL OZ)

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

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

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

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

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)
EQUATE Antiseptic Mouthwash Green Mint
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, sodium benzoate, benzoic acid, sodium saccharin, flavor, D&C yellow #10, FD&C green #3

Questions Or Comments (Questions or comments)

1-888-287-1915

Principal Display Panel (Principal display panel)

Compare to Listerine® Freshburst® active ingredients*

Antiseptic Mouthwash

Green Mint

Kills germs that cause plaque, gingivitis bad breath

Help to control and prevent plaque that leads to gingivitis

Eucalyptol (0.092%)

Menthol (0.042%)

Methyl salicylate (0.060%)

Thymol (0.064%)

Antiplaque/antigingivitis

L (QT PT FL OZ)

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

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

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

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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