Spotlight Oral Care Kit for Sensitive Teeth

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]

SPOTLIGHT ORAL CARE KIT FOR SENSITIVE TEETH- kit for sensitive teeth 
Oral Spotlight Care Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Spotlight Oral Care Kit for Sensitive Teeth

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

Drug Facts

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

(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

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

(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. If more than used for
brushing is accidentally swallowed, get medical help or
contact a Poison Control Center right away.

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)

Directions                                                                                                                   

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

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 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

Kit Lbl-SensTeeth

009 Tube

Gel for SensTeth

SensTeth M-wash

res

SPOTLIGHT ORAL CARE KIT FOR SENSITIVE TEETH 
kit for sensitive teeth kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75065-011
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-011-051 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package07/02/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 100 g
Part 21 BOTTLE 30 mL
Part 31 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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-009-021 in 1 CARTON
1100 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/11/2021
Part 2 of 3
ANTICAVITY FLUORIDE FOAMING MOUTHWASH FOR STRENGTHENING ENAMEL 
sodium fluoride liquid
Product Information
Item Code (Source)NDC: 75065-013
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-013-0330 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/09/2021
Part 3 of 3
ANTICAVITY FLUORIDE GEL FOR SENSITIVE TEETH 
sodium fluoride gel
Product Information
Item Code (Source)NDC: 75065-014
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.24 g  in 100 mL
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-014-0415 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/02/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/02/202112/31/2023
Labeler - Oral Spotlight Care Inc (117405870)

Revised: 1/2023