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Amerfresh Package Insert

Status:
Prescription (Rx) Facts
Strength:
2.2 mg/g
Active ingredient:
Similar drugs:

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

Prescribing information (package insert) - Amerfresh

Active Ingredients

Sodium fluoride-0.22%

Purpose

Anticavity Toothpaste.

Uses

aids in the prevention of dental cavities

Warnings

  • Keep out of the reach of children under 6 years of age .
  • If more than used for brushing is accidently swallowed ,get medical help or contact a Poison Control Center right away.

Directions

  • Adults and children 6 years of age and older .Brush teeth thoroughly ,preferably after each meal or at least twice a day,or as directed by a dentist.
  • Do not swallow.
  • To minimize the swallowing ,use a pea-sized amount in children under 6 years old.
  • Supervise children’s brushing until good habits are established.
  • Children under 2 yrs : ask a dentist before use

Inactive Ingredients

Calcium Carbonate, Water,Sorbitol,Hydrated Silica, Sodium Lauryl Sulphate,Sodium Carboxymethyl cellulose, Flavor, Sodium Saccharin, Sodium methyl paraben, Sodium propyl paraben.

About this document

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

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Drug information for Amerfresh

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 2.2 mg/g
Dosage form Paste
Route Dental
Marketing status not in the current FDA NDC Directory
Company (applicant) SUHAN AEROSOL
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
2.2 mg/g – 7.1 g in 1 pouch NDC 73398-114-01

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.