FDA Label for Amerfresh Fluoride

View Indications, Usage & Precautions

Amerfresh Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Amercare Products, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Sodium Fluoride 0.22% (0.1% w/v fluoride ion)


Purpose



Anticavity toothpaste


Use



aids prevention of dental cavities


Keep Out Of Reach Of Children Under 6 Yrs. Of Age



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


Directions



  • Adults and children 2 yrs. and older:  Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist.
  • Do not swallow
  • To minimize 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



sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium carboxymethyl cellulose, flavor, sodium saccharine, sodium methyl paraben, sodium propyl paraben.


Package Labeling:




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