Pcxx Naf Rns Mint

Pcxx Naf Rns Mint
SPL v1
SPL
SPL Set ID 5e95fcb1-0e77-b35e-e053-2a91aa0a20a7
Routes
TOPICAL DENTAL
Published
Effective Date 2017-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.04 mg)
Inactive Ingredients
Potassium Sorbate Xylitol Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-11-22

Description

Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out vigorously swish 10 milliliters 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 until capable of using without supervision children under 6 years of age: consult a dentist or doctor.


Medication Information

Warnings and Precautions

Keep out of reach of children.

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

Indications and Usage

Aids in the prevention of dental cavities

Dosage and Administration

Adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste

remove cap

hold bottle upright and squeeze. Fill to FILL LINE

pour out. Only the correct 10 milliliters dose will pour out

vigorously swish 10 milliliters 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 until capable of using without supervision

children under 6 years of age: consult a dentist or doctor.

Description

Adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste remove cap hold bottle upright and squeeze. Fill to FILL LINE pour out. Only the correct 10 milliliters dose will pour out vigorously swish 10 milliliters 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 until capable of using without supervision children under 6 years of age: consult a dentist or doctor.

Section 51727-6

potassium sorbate, xylitol, sucralose, water

Section 51945-4

Section 55105-1

Anticavity

Section 55106-9

Sodium Fluoride 0.05%


Structured Label Content

Indications and Usage (34067-9)

Aids in the prevention of dental cavities

Dosage and Administration (34068-7)

Adults and children 6 years of age and older:

use once a day after brushing your teeth with a toothpaste

remove cap

hold bottle upright and squeeze. Fill to FILL LINE

pour out. Only the correct 10 milliliters dose will pour out

vigorously swish 10 milliliters 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 until capable of using without supervision

children under 6 years of age: consult a dentist or doctor.

Warnings and Precautions (34071-1)

Keep out of reach of children.

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

Section 51727-6 (51727-6)

potassium sorbate, xylitol, sucralose, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)

Sodium Fluoride 0.05%


Advanced Ingredient Data


Raw Label Data

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