FDA Label for Amerfresh
View Indications, Usage & Precautions
Amerfresh 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.
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Drug Facts
Exclusive Distributor: AMERCARE Products Inc., Seattle., WA 98165-2226.
Active Ingredient
Sodium monofluorophosphate 0.76% (0.1 w/v fluoride ion)
Purpose
Anticavity toothpaste
Use
aids in the prevention of dental cavities
Otc - Keep Out Of Reach Of Children
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 immediately.
Directions For Use
- wet toothbrush and dip into powder until brush is fully covered
- brush teeth and gum line for at least 30 seconds, rinse and spit out thoroughly
- Do not swallow
- supervise children as necessary until capable of using without supervision
- Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing).
- 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 or a doctor.
- Children under 6 years of age: Do not use unless directed by a doctor or dentist
Inactive Ingredients
calcium carbonate, sodium carboxymethyl cellulose, sodium saccharin, sodium lauryl sulfate, flavour, silica, sodium methyl paraben, sodium propyl paraben, CI 16255 Q.S.
Principal Display Panel - 57 G Packet Label
AMERFRESH®
FLUORIDE TOOTHPOWDER
NET WT. 2 oz (57g)
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