Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
f7edf75c-cdba-4dde-bfc5-a04af34759d3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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
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)
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:30.644658 · Updated: 2026-03-14T23:13:25.872506