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

Purpose

Antigingivitis/Antiplaque

Description

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


Medication Information

Uses

helps prevent and reduce

  • plaque
  • gingivitis
Purpose

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
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

Description

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

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.

Purposes

Antigingivitis/Antiplaque

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%)

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
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
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.

Purposes

Antigingivitis/Antiplaque

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%)

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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