AMERFRESH FLUORIDE- sodium fluoride 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]

Drug Facts

Active Ingredient

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

Purpose

Anticavity toothpaste

Use

aids prevention of dental cavities

Warnings

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:

INGREDIENTS AND APPEARANCE

AMERFRESH FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51460-3030
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51460-3030-1	7.1 g in 1 PACKET; Type 0: Not a Combination Product	10/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/12/2016

Labeler - Amercare Products, Inc. (879289254)