ADVANCED WHITENING ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice

Advanced Whitening Anticavity Fluoride by

Drug Labeling and Warnings

Advanced Whitening Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Personal Care Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste

Uses

aids in the prevention of cavities

Warnings

If more than used for brushing is accidentally swallowed get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

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

Directions

• adults and children 2 years. 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

calcium carbonate, calcium hydrogen phosphate, carboxymethyl cellulose, flavor, glycerin, hydrated alumina, hydrated silica, potassium sorbate, saccharin sodium, sodium lauryl sulfate, sorbitan monooleate, sorbitol, titanium dioxide, water, xanthan gum.

Advanced Whitening Anticavity product label

Personal Care™

Advanced Whitening Anitcavity Fluoride Toothpaste

FRESH MINT

Fights Tarter Build-up

NET WT 6.4 OZ. (181 G)

Free Soft Toothrush

Distributed by:
Personal Care Products, LLC
Troy, Michigan 48084 U.S.A.
Made in China

INGREDIENTS AND APPEARANCE

ADVANCED WHITENING ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29500-9223
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1000 mg  in 181 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
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: 29500-9223-6	1 in 1 BOX	07/24/2017
1		181 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/24/2017

Labeler - Personal Care Products, LLC (966155082)

Registrant - Personal Care Products, LLC (966155082)