Spotlight Oral Care Kit for Sensitive Teeth

Manufacturer
Oral Spotlight Care Inc
Effective date
2023-01-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:40:12

Label at a glance#

ProductSpotlight Oral Care Kit for Sensitive Teeth
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure12 sections

Label contents#

Full prescribing information#

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

OTC - ACTIVE INGREDIENT SECTION

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)

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION

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 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 SECTION

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


OTC - QUESTIONS SECTION

Questions or comments? +1 (646) 9806461

Kit for Sensitive Teeth Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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-SensTeethKit Lbl-SensTeeth

009 Tube009 Tube

Gel for SensTethGel for SensTeth

SensTeth M-washSensTeth M-wash

res

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Ingredients#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e7f26307-f6ea-4799-b047-955c8919b7e2f04de34f-4d73-4906-9e9f-38f25efd009e2023-01-18WarningsExact identifier
spl id: e7f26307-f6ea-4799-b047-955c8919b7e2
spl set id: f04de34f-4d73-4906-9e9f-38f25efd009e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.