ADVANCED WHITENING ANTI CAVITY FLUORIDE- sodium monofluorophosphate paste

ADVANCED WHITENING ANTI CAVITY FLUORIDE by

Drug Labeling and Warnings

ADVANCED WHITENING ANTI CAVITY FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Monofluorophosphate  0.76%

(1000 ppm)

PURPOSE

Purpose

Anticavity toothpaste

INDICATIONS & USAGE

Uses

• builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
• aids in the prevention of dental cavities.

WARNINGS

Warning

WHEN USING

When using this product

• if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.

STOP USE

Stop and ask a dentist

• if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Directions

• adults and children of 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 years: ask a dentist before use.

Children under 12 years of age: Consult a dentist or doctor

SPL UNCLASSIFIED SECTION

Other information

• store in a cool, dry place.

INACTIVE INGREDIENT

Inactive Ingredients

Calcium carbonate, Water, Glycerine, Silica, Sodium Lauryl sulphate, Sorbitol, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium carboxy methyl cellulose, Flavor and FD&C blue #1

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

INGREDIENTS AND APPEARANCE

ADVANCED WHITENING ANTI CAVITY FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-108
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-108-01	181 g in 1 TUBE; Type 0: Not a Combination Product	05/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/18/2020

Labeler - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Lifesciences		675474890	manufacture(52000-108)