Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc

Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
SPL v6
SPL
SPL Set ID 269b9e7f-c5c8-4023-a3ea-e39040ade271
Route
ORAL
Published
Effective Date 2025-10-28
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-01

Description

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

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

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

Uses

helps prevent and reduce

  • plaque
  • gingivitis
Purposes

Antigingivitis/Antiplaque

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 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 (21.6% v/v), sorbitol, poloxamer 407, sodium benzoate, benzoic acid, sodium saccharin, flavor, FD&C green no. 3

Principal Display Panel

*Compare to the active ingredients in Listerine® Cool Mint®*

BLUE MINT

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 (qt fl oz)

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

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 USA

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

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

Antigingivitis/Antiplaque

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 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 (21.6% v/v), sorbitol, poloxamer 407, sodium benzoate, benzoic acid, sodium saccharin, flavor, FD&C green no. 3

Principal Display Panel (Principal display panel)

*Compare to the active ingredients in Listerine® Cool Mint®*

BLUE MINT

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 (qt fl oz)

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

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 USA

NOT 100% SATISFIED? Return within 30 days to the store of purchase for a refund (with receipt) or exchange.

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

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