ANTI CAVITY FLUORIDE- sodium monofluorophosphate paste

ANTI CAVITY FLUORIDE by

Drug Labeling and Warnings

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 Monofluorophosphate  0.76%

(Total Fluoride Content - 1000 ppm approx.)

PURPOSE

Purpose

Anticavity toothpaste

INDICATIONS & USAGE

Uses

• regular brushing with flouride toothpaste helps protect teeth againts 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 under 6 years of age

• If accidentally swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• adults and children of 6 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 pea-sized amount in children under 6 years old.
• supervise child's brushing until good habits are established.
• children under 2 years: ask a dentist before use.

SPL UNCLASSIFIED SECTION

Other information

• store in a cool, dry place.

INACTIVE INGREDIENT

Inactive Ingredients

calcium carbonate, flavor, methylparaben, poly ethylene glycol 400, precipited silica, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, tetra sodium pyrophosphate, titanium dioxide, water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

ANTI-CAVITY FLUORIDE TOOTHPASTE

INGREDIENTS AND APPEARANCE

ANTI CAVITY FLUORIDE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-036
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
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: 52000-036-46	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(52000-036)