SPOTLIGHT ORAL CARE KIT FOR SENSITIVE TEETH- kit for sensitive teeth kit

Spotlight Oral Care Kit for Sensitive Teeth by

Drug Labeling and Warnings

Spotlight Oral Care Kit for Sensitive Teeth by is a Otc medication manufactured, distributed, or labeled by Oral Spotlight Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Kit contains:
Anticavity Toothpaste for Sensitive Teeth +
Anticavity Gel for Sensitive Teeth +
Foaming Anticavity Mouthwash for Sensitive Teeth

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

(Anticavity Toothpaste)
Potassium Nitrate 5%
Sodium Fluoride 0.24% (0.10% W/V fluoride ion)

(Anticavity Gel)
Potassium Nitrate 5%
Sodium Fluoride 0.24% (0.15% W/V fluoride ion)

(Foaming Anticavity Mouthwash)
Sodium Fluoride 0.05% (0.02% W/V fluoride ion)

PURPOSE

Purpose

(Anticavity Toothpaste only)
Potassium Nitrate .......... For sensitive teeth
Sodium Fluoride ............ Anticavity

(Anticavity Gel only)
Potassium Nitrate .......... For sensitive teeth
Sodium Fluoride ............ Anticavity

(Foaming Anticavity Mouthwash)
Sodium Fluoride ......... Anticavity

INDICATIONS & USAGE

Uses

(Anticavity Toothpaste)
helps reduce painful sensitivity of the teeth to cold,
heat, acids, sweets, or contact.
Builds increasing protection against painful sensitivity
of the teeth to cold, heat, acids, sweets, or contact.
Aids in the prevention of dental cavities.

(Anticavity Gel)
helps reduce painful sensitivity of the teeth to cold,
heat, acids, sweets, or contact.
Builds increasing protection against painful sensitivity
of the teeth to cold, heat, acids, sweets, or contact.
Aids in the prevention of dental cavities.

Use

(Foaming Anticavity Mouthwash)
Aids in the prevention of dental decay.

WARNINGS

Warnings

(Anticavity Toothpaste)
When using this product do not use longer than 4
weeks unless recommended by a dentist or doctor.
Stop use and ask a dentist if the problem persists
or worsens. Sensitive teeth may indicate a serious
problem that may need prompt care by a dentist.

(Anticavity Gel)
When using this product do not use longer than 4
weeks unless recommended by a dentist or doctor.
Stop use and ask a dentist if the problem persists
or worsens. Sensitive 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 more than used for
brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

(Anticavity Toothpaste)
Adults and children 12 years of age and older: Apply
at least a 1-inch strip of the product onto a soft bristle
toothbrush. Brush teeth thoroughly for at least 1
minute twice a day (morning and evening) or as
recommended by a dentist or doctor. Make sure to
brush all sensitive areas of the teeth. Children under
12 years of age: Consult a dentist or doctor.

(Anticavity Gel)
Adults and children 12 years of age and older: Apply
at least a 1-inch strip of the product onto a soft bristle
toothbrush. Brush teeth thoroughly for at least 1
minute twice a day (morning and evening) or as
recommended by a dentist or doctor. Make sure to
brush all sensitive areas of the teeth. Children under
12 years of age: Consult a dentist or doctor.

(Foaming Anticavity Mouthwash)

• Adults and children 6 years of age and older:

  Use once a day after brushing

  your teeth with a toothpaste.

  Vigorously swish 10 milliliters

  of rinse between your teeth

  for 1 minute and then spit

  out. Do not swallow the rinse.

  Do not eat or drink for 30

  minutes after rinsing.

• Children under 12 years of age:

  Instruct in good brushing and

  rinsing habits (to minimize

  swallowing), Supervise children

  as necessary until capable of

  using without supervision.

• Children under 6 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information
Do not use if outer container is open or if
sticker seal on the lid is missing or broken.

INACTIVE INGREDIENT

Inactive Ingredients

(Anticavity Toothpaste)
Sorbitol, Water (purified), Hydrated Silica,
Glycerin, Tricalcium Phosphate, Flavor, Xanthan
Gum, Cocamidopropyl Betaine, Sodium
Saccharin, Sodium Benzoate, Titanium Dioxide

(Anticavity Gel)
Water (purified), Vegetable Glycerin, Sodium
Carboxymethylcellulose, Xylitol, Flavor,
Sodium Saccharin, Monosodium Phosphate,
Hydrated Silica

(Foaming Anticavity Mouthwash)
Water, Xylitol, Glycerin, Poloxamer 407,
Cocamidopropyl Betaine, Chinese Mint (Mentha
Arvensis) Oil, Hydroxyapatite, Potassium Citrate,
Tocopherol, Sodium Saccharin, Calcium Gluconate,
Sodium Chloride, Sodium Benzoate

QUESTIONS

Questions or comments? +1 (646) 9806461

Kit for Sensitive Teeth Labeling

Spotlight Oral Care

S

Kit for Sensitive Teeth

Contains

Sodium Fluoride

Potassium Nitrate

Fluoride AnticavityToothpaste Net Wt. 3.5 oz (100 g) +
Fluoride Anticavity Foaming Mouthwash for Strengthening Enamel 1 fl oz (30 ml)+
Fluoride Anticavity Gel for Sensitive Teeth 0.5 fl oz (15 ml)

MADE IN THE USA

Distributed by Spotlight Oral Care INC,

90 South Dale, Suite #8, Saint Paul,

Minnesota, USA 55102

res

INGREDIENTS AND APPEARANCE

SPOTLIGHT ORAL CARE KIT FOR SENSITIVE TEETH 
kit for sensitive teeth kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-011

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-011-05	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	07/02/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 g
Part 2	1 BOTTLE	30 mL
Part 3	1 TUBE	15 mL

Part 1 of 3

SPOTLIGHT ORAL CARE FOR SENSITIVE TEETH 
potassium nitrate, sodium fluoride paste

Product Information
Item Code (Source)	NDC: 75065-009
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-009-02	1 in 1 CARTON
1		100 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/11/2021

Part 2 of 3

ANTICAVITY FLUORIDE FOAMING MOUTHWASH FOR STRENGTHENING ENAMEL 
sodium fluoride liquid

Product Information
Item Code (Source)	NDC: 75065-013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.05 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
TOCOPHEROL (UNII: R0ZB2556P8)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-013-03	30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/09/2021

Part 3 of 3

ANTICAVITY FLUORIDE GEL FOR SENSITIVE TEETH 
sodium fluoride gel

Product Information
Item Code (Source)	NDC: 75065-014
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 mL
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
XYLITOL (UNII: VCQ006KQ1E)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-014-04	15 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/02/2021

Labeler - Oral Spotlight Care Inc (117405870)