ADVANCED WHITENING ANTI CAVITY FLUORIDE- sodium fluoride 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, Yangzhou Holyshine Industrial Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

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 12 years of age and older:

• apply at least a 1-inch strip of product onto soft bristle toothbrush
• brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
• make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after  brushing.

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, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

INGREDIENTS AND APPEARANCE

ADVANCED WHITENING ANTI CAVITY FLUORIDE 
sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-035
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
SORBITOL (UNII: 506T60A25R)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-035-46	1 in 1 BOX	06/21/2017
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	06/21/2017

Labeler - Universal Distribution Center LLC (019180459)

Registrant - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Holyshine Industrial Co. Ltd		421141948	manufacture(52000-035)