Kalaya Breath Refresh Antiseptic Oral Rinse-updated Label For Ndc
1666fff6-9a8b-40f9-ae53-914152db386b
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)
Purpose
Anticavity rinse
Medication Information
Purpose
Anticavity rinse
Description
Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)
Uses
aids in the prevention of dental cavities
Purposes
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
Package Label
Active Ingredient
Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)
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
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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
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
Purposes
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
Package Label (Package label)
Active Ingredient (Active ingredient)
Sodium fluoride 0.02% w/v (0.01% w/v fluoride ion)
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
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
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
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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:06:37.853354 · Updated: 2026-03-14T23:09:29.869893