AMERFRESH- sodium monofluorophosphate powder

Amerfresh by

Drug Labeling and Warnings

Amerfresh by is a Otc medication manufactured, distributed, or labeled by Amercare Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACTS

Active Ingredient

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warning

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

• 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 physician.
• Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing to minimize swallowing.
• Children under 2 years: Ask a Dentist or physician.

Inactive Ingredients

Calcium Carbonate, Sodium Carboxy Methyl Cellulose, Sodium Saccharin, Sodium Lauryl Sulfate, Flavour, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium and Cl 16255 Q.S.

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Exclusive Distributor: AMERCARE Products Inc. Seattle. WA 98165-2226.

PRINCIPAL DISPLAY PANEL - 446 g Carton

AMERFRESH®
FLUORIDE TOOTHPOWDER

NET WEIGHT 1 lb (446 g)

INGREDIENTS AND APPEARANCE

AMERFRESH 
sodium monofluorophosphate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-0502
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O)	Sodium Monofluorophosphate	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Calcium Carbonate (UNII: H0G9379FGK)	94.98 g  in 100 g
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Methylparaben Sodium (UNII: CR6K9C2NHK)
Propylparaben Sodium (UNII: 625NNB0G9N)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Ponceau 4R (UNII: Z525CBK9PG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-0502-1	446 g in 1 POUCH
2	NDC: 51460-0502-2	57 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/1996

Labeler - Amercare Products Inc (879289254)