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
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
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)
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
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