zohar anti-cavity mouthwash coolmint flavour

SPL v1

SPL

SPL Set ID a35355f3-c96d-4085-b4da-7e695dc73888

Route

dental

Published

Effective Date 2024-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (0.2 mg)

Inactive Ingredients

water xylitol glycerin sodium benzoate sodium citrate saccharin sodium citric acid monohydrate poloxamer 407 fd&c blue no. 1

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-03-15

Purpose

Anticavity

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Medication Information

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:
use once a day after brushing your teeth with a toothpaste
vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat 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 untill capable of using without supervision.
Children under 6 years of age:consult a dentist or doctor.

Inactive Ingredients

Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.

Description

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Drug Facts

Active Ingredient

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

Keep Out of Reach of Children.

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Purpose

Anticavity

Directions

Adults and children 6 years of age and older:
use once a day after brushing your teeth with a toothpaste
vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
do not swallow the rinse
do not eat 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 untill capable of using without supervision.
Children under 6 years of age:consult a dentist or doctor.

Inactive Ingredients (Inactive ingredients)

Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.

Use

Aids in the prevention of dental cavities

Label

Drug Facts

Active Ingredient (Active ingredient)

Sodium fluoride 0.05% (0.02% w/v fluoride ion)

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 right away.

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "0.2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Directions": "Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste vigorously swish 10 ml (2teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat 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 untill capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.", "Active ingredient": "Sodium fluoride 0.05% (0.02% w/v fluoride ion)", "Inactive ingredients": "Water, Xylitol, Glycerin, Sodium Benzoate, Flavor, Sodium Citrate, Sodium Saccharin, Citric Acid, Poloxamer 407, FD&C Blue #1.", "Keep out of reach of children.": "If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:51.907855 · Updated: 2026-03-14T23:02:39.250584