UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE- potassium nitrate and sodium fluoride paste

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE by

Drug Labeling and Warnings

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE by is a Otc medication manufactured, distributed, or labeled by Universal Distribution Center LLC, Orchid Lifesciences. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

PURPOSE

Purpose

Antihypersensitivity

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

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

INGREDIENTS AND APPEARANCE

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52000-109
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52000-109-01	122 g in 1 TUBE; Type 0: Not a Combination Product	05/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/20/2020

Labeler - Universal Distribution Center LLC (019180459)

Establishment
Name	Address	ID/FEI	Business Operations
Orchid Lifesciences		675474890	manufacture(52000-109)