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Take Home Fluoride Cool Mint Package Insert

Status:
Prescription (Rx) Facts
Strength:
5 mg/g
Brand names:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Take Home Fluoride Cool Mint

INDICATIONS

Helps prevent dental caries and hypersensitivity.

ACTIVE INGREDIENT

Sodium Fluoride 1.1% (0.5% Fluoride Ion)

OTHER INGREDIENTS

Purified water, glycerin, Xylitol and other sweeteners. Contains FD&C Blue #1

DIRECTIONS

Adults and children six years of age and older should brush with PATTERSON BRAND TAKE HOME FLUORIDE 1.1% NEUTRAL SODIUM FLUORIDE GEL, once at bedtime.

  1. 1. Apply thin bead of gel to toothbrush and brush for at least one minute making sure all tooth surfaces are covered.
  2. 2.

    Adults: expectorate thoroughly. Do not rinse, eat, or drink for at least 30 minutes after use.

    Children 6 and older: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste.

WARNINGS

DO NOT SWALLOW. Supervision is required while children are using this product in order to avoid ingestion. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF INFANTS & CHILDREN.

PRECAUTIONS

For Professional Use only. Federal (USA) law prohibits dispensing without a prescription. Store at controlled room temperature 68° -77° F (20° - 25°C).

NDC# 5022710062

Manufactured in the USA

Questions? Call your dentist for more information.

Distributed by

Patterson Dental Supply, Inc.

1031 Mendota Heights Road

St. Paul, MN 55120

Reorder# 088-6093 12/Case

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Take Home Fluoride Cool Mint

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 5 mg/g
Dosage form Gel, dentifrice
Route Dental
Marketing status not in the current FDA NDC Directory
Company (applicant) Patterson Dental Supply Inc
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg/g – 56 g in 1 tube / 1 in 1 box, unit-dose NDC 50227-1006-2

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.