AMERFRESH FLUORIDE GEL- sodium fluoride paste, dentifrice

AMERFRESH FLUORIDE gel by

Drug Labeling and Warnings

AMERFRESH FLUORIDE gel by is a Otc medication manufactured, distributed, or labeled by Yangzhou ONE & ONLY Personal Care Products Co., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Purpose

anticavity toothpaste

Uses

Aids in the prevention of dental cavities.

Warnings

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.

Keep out of reach of children.

Directions

• do not swallow
• supervise children as necessary until capable of useing 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 physician.
• Children under 6 years of age:do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

Sorbitol, Hydrated Silica, Water, PEG-8, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Glycerin, anthan Gum, Sodium Benzoate, Cetylpyridinium Chloride.    

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMERFRESH FLUORIDE GEL 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85162-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85162-001-01	144 in 1 BOX	01/16/2025
1		17 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 85162-001-02	144 in 1 BOX	01/16/2025
2		24 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 85162-001-03	144 in 1 BOX	01/16/2025
3		43 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 85162-001-04	144 in 1 BOX	01/16/2025
4		78 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 85162-001-05	144 in 1 BOX	01/16/2025
5		85 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 85162-001-06	144 in 1 BOX	01/16/2025
6		142 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 85162-001-07	1000 in 1 BOX	01/16/2025
7		7 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/16/2025

Labeler - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)

Registrant - Yangzhou ONE & ONLY Personal Care Products Co., LTD (458091296)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou ONE & ONLY Personal Care Products Co., LTD		458091296	manufacture(85162-001)