AMERFRESH FLUORIDE- sodium monofluorophosphate paste

AmerFresh Fluoride by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Use

Aids in the prevention of dental cavities

Warnings

If more than used for brushing is accidently swallowed, get medical help or contact a poison control center

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 yrs. of age

Directions

• Adults and children 2 yrs. and older: Brush teeth throughtly 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

SODIUM MONOFLUOROPHOSPHATE, CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, CARBOXYMETHYLCELLULOSE, GLYCERIN, ALUMINUM HYDROXIDE, HYDRATED SILICA, POTASSIUM SORBATE, SODIUM LAURYL SULFATE, SORBITAN MONOOLEATE, SORBITOL, TITANIUM DIOXIDE, WATER, XANTHAN GUM.

AmerFresh Fluoride Gel Toothpaste

INGREDIENTS AND APPEARANCE

AMERFRESH FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-3002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-3002-1	17 g in 1 TUBE; Type 0: Not a Combination Product	09/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/12/2016

Labeler - Amercare Products, Inc. (879289254)

Registrant - Amercare Products, Inc. (879289254)