Acclean (Gelato sodium fluoride, Nafrinse) Package Insert

Prescribing information (package insert) - Acclean

Indications: Helps prevent dental caries and hypersensitivity

Directions: Adults and children six years of age and older should brush with

Acclean Home Care Gel once at bedtime. Apply thin bead of gel to toothbrush

and brush for at least one minute, making sure all tooth surfaces are covered.

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

after use. Children six years of age and older: expectorate and rinse thoroughly.

If recommended by your dentist professional, this product can be used in place

of your regular toothpaste.

WARNINGS: DO NOT SWALLOW. To avoid ingestion,

supervision is required while children are using this product.

Swallowing excessive amounts of fluoride could cause dental fluorosis.

KEEP OUT OF REACH OF INFANTS AND CHILDREN.

Enter section text here PRECAUTIONS: Federal (USA) Law

prohibits dispensing without prescription. Store at controlled

room temperature 68 - 77 F (20 - 25 C).

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 Acclean

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

Oral

Marketing status

not in the current FDA NDC Directory

Company (applicant)

Henry Schein 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 NDC 0404-8016-02

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.