kalaya breath refresh antiseptic oral rinse-updated label for ndc

kalaya breath refresh antiseptic oral rinse-updated label for ndc
SPL v2
SPL
SPL Set ID 1666fff6-9a8b-40f9-ae53-914152db386b
Route
oral
Published
Effective Date 2025-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (.1 mg)
Inactive Ingredients
water alcohol sorbitol poloxamer 407 eucalyptol methyl salicylate thymol sucralose saccharin sodium phosphoric acid menthol disodium phosphate fd&c red no. 40 fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
otc monograph drug active Since 2025-06-02

Purpose

Anticavity rinse

Description

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)


Medication Information

Uses

aids in the prevention of dental cavities

Purpose

Anticavity rinse

Directions

adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not each or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Other Information
  • store at room temperature
  • cold weather may cloud this product
Inactive Ingredients

water, alcohol (21.6% v/v), sorbitol, poloxamer 407, flavor, eucalyptol, methyl salicylate, thymol, sucralose, sodium saccharin, phosphoric acid, menthol, disodium phosphate, FD&C red no. 40. FD&C blue no. 1

Description

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)

Principal Display Panel

*Compare to the active ingredients in Listerine® Total Care Anticavity Mouthwash

Purple Mint

Anticavity

Fluoride Rinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

PURPLE MINT FLAVOR ANTICAVITY

FLUORIDE MOUTHWASH

6 IN 1 BENEFITS:

  • Helps prevent cavities
  • Restores enamel
  • Helps to strengthen teeth
  • Leaves the mouth feeling clean
  • Freshens breath
  • Cleans the entire mouth**

Important: Read directions for proper use.

L (qt fl oz)

*This product is not manufactured or distributed by Kenvue Inc., distributor of Listerine® Total Care Anticavity Mouthwash.

**This product is not intended to replace brushing or flossing.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

Purposes

Anticavity rinse

Package Label
Anticavity Fluoride Rinse Purple Mint
Anticavity Fluoride Rinse Purple Mint
Active Ingredient

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)

Questions Or Comments?

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

Keep Out of Reach of Children

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

aids in the prevention of dental cavities

Directions

adults and children 12 years of age and older:

  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not each or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

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, flavor, eucalyptol, methyl salicylate, thymol, sucralose, sodium saccharin, phosphoric acid, menthol, disodium phosphate, FD&C red no. 40. FD&C blue no. 1

Principal Display Panel (Principal display panel)

*Compare to the active ingredients in Listerine® Total Care Anticavity Mouthwash

Purple Mint

Anticavity

Fluoride Rinse

Sodium Fluoride and Acidulated Phosphate Topical Solution

PURPLE MINT FLAVOR ANTICAVITY

FLUORIDE MOUTHWASH

6 IN 1 BENEFITS:

  • Helps prevent cavities
  • Restores enamel
  • Helps to strengthen teeth
  • Leaves the mouth feeling clean
  • Freshens breath
  • Cleans the entire mouth**

Important: Read directions for proper use.

L (qt fl oz)

*This product is not manufactured or distributed by Kenvue Inc., distributor of Listerine® Total Care Anticavity Mouthwash.

**This product is not intended to replace brushing or flossing.

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA

Purposes

Anticavity rinse

Package Label (Package label)
Anticavity Fluoride Rinse Purple Mint
Anticavity Fluoride Rinse Purple Mint
Active Ingredient (Active ingredient)

Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)

Questions Or Comments? (Questions or comments?)

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

Keep Out of Reach of Children (Keep out of reach of children)

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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