AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH- sodium monofluorophosphate paste, dentifrice

AquaWhite Blue Gel Cavity FightingTooth by

Drug Labeling and Warnings

AquaWhite Blue Gel 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:

Sorbitor, Water, Silica, Glycerin, Sodium Lauryl Suphate, Flavor, PEG-1500, Sodium Carboxymethylcellulose, Xylitol, Xanthan Gum, Sodium Methyl Paraben, Sodium Phosphate, Sodium Propyl Paraben, Sodium Saccharin, Cooling Crystal, FD&C Blue 1

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUAWHITE BLUE GEL CAVITY FIGHTINGTOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72025-002
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
SODIUM PHOSPHATE (UNII: SE337SVY37)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72025-002-01	80 g in 1 TUBE; Type 0: Not a Combination Product	01/16/2018
2	NDC: 72025-002-02	150 g in 1 TUBE; Type 0: Not a Combination Product	01/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/16/2018

Labeler - JHS SVENDGAARD LABORATORIES LIMITED (675939900)

Establishment
Name	Address	ID/FEI	Business Operations
JHS SVENDGAARD LABORATORIES LIMITED		675939900	manufacture(72025-002)