AQUAWHITE CAVITY FIGHTINGTOOTH- sodium monofluorophosphate paste, dentifrice

AquaWhite Cavity FightingTooth by

Drug Labeling and Warnings

AquaWhite Cavity FightingTooth by is a Otc medication manufactured, distributed, or labeled by JHS SVENDGAARD LABORATORIES LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose:

Anticavity

INDICATIONS & USAGE

Uses:

Helps protect  against cavities

WARNINGS

Warnings:

If you accidentally swallow more than used for brushing, seek professional help 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age

DOSAGE & ADMINISTRATION

Directions:

• Adults and children 2 years and older:
• Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• Do not swallow
• Children under 6 Years of Age

• To minimize swallowing use a pea-sized amount and supervise children's brushing untill good habits are established.

Children under 2 years of age:

• Ask a dentist or physician

INACTIVE INGREDIENT

Inactive Ingredients:

Caldium Carbonate, Sorbitor, Water, Silica, Sodium Lauryl Suphate, Titanium Dioxide, Flavor, Sodium Carboxymethylcellulose, Sodium Silicate, Xanthan Gum, Sodium Saccharin, Formaldehyde

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUAWHITE CAVITY FIGHTINGTOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72025-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM SILICATE (UNII: IJF18F77L3)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72025-001-01	18 g in 1 TUBE; Type 0: Not a Combination Product	11/29/2016
2	NDC: 72025-001-02	35 g in 1 TUBE; Type 0: Not a Combination Product	11/29/2016
3	NDC: 72025-001-03	100 g in 1 TUBE; Type 0: Not a Combination Product	11/29/2016
4	NDC: 72025-001-04	200 g in 1 TUBE; Type 0: Not a Combination Product	11/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/28/2016

Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)

Establishment
Name	Address	ID/FEI	Business Operations
JHS SVENDGAARD LABORATORIES LIMITED		675939900	manufacture(72025-001)