SPOTLIGHT ORAL CARE KIT FOR BAD BREATH- kit for bad breath kit

Spotlight Oral Care Kit for Bad Breath by

Drug Labeling and Warnings

Spotlight Oral Care Kit for Bad Breath 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 Bad Breath

Foaming Anticavity Mouthwash for Bad Breath

Mouth Spray for Bad Breath

Drug Facts

Active ingredient (Anticavuty Toothpaste only)

Sodium Fluoride 0.24% (0.10% W/V fluoride ion)

Active ingredient (Foaming Anticavity Mouthwash for Bad Breath only)

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

PURPOSE

Purpose Anticavity

INDICATIONS & USAGE

Use Aids in the prevention of dental decay.

WARNINGS

Warnings

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 (Anticavuty Toothpaste only)

• Adults and children 2 years of age and older:

  Brush teeth thoroughly, preferably after

  each meal or at least twice a day, or as

  directed by a dentist or doctor.

• Children under 6 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 2 years of age:

  Consult a dentist or doctor.

Directions (Foaming Anticavity Mouthwash for Bad Breath only)

• Adults and children 6 years of age and older:

  Use once a day after brushing your; teeth with a toothbrush. 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 yearsof 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 only)
Sorbitol, Water (purified), Hydrated Silica, Glycerin,
Sodium Bicarbonate, Pentasodium Triphosphate,
Cocamidopropyl Betaine, Cellulose Gum, Titanium Dioxide,
Zinc Lactete, Flavor

Inactive Ingredients (Foaming Anticavity Mouthwash for Bad Breath only)
Water (purified), Xylitol, Poloxamer 407, Cocamidopropyl
Betaine, Chinese Mint (Mentha Arvensis) Oil, Sodium
Saccharin, Tocopherol, Zinc Citrate, Sodium Chloride,
Benzoic Acid, Benzyl Alcohol

QUESTIONS

Questions? +1 (646) 9806461

Kit for Bad Breath Labeling

Spotlight Oral Care

B

Kit for Bad Breath

Contains

Sodium Fluoride

Fluoride AnticavityToothpaste NetWt. 3.5 oz (100 g) +
Auoride Anticavity Foaming Mouthwash for Bad Breath1fl oz (30 ml)+
Mouth Sprayfor Bad Breath 0.7ft oz (20 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 BAD BREATH 
kit for bad breath kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75065-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-010-05	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package	06/28/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 g
Part 2	1 BOTTLE	30 mL
Part 3	1 BOTTLE, SPRAY	20 mL

Part 1 of 3

SPOTLIGHT ORAL CARE FOR GUM HEALTH 
sodium fluoride paste

Product Information
Item Code (Source)	NDC: 75065-006
Route of Administration	DENTAL

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 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ZINC LACTATE (UNII: 2GXR25858Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-006-02	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 final	part355	06/11/2021

Part 2 of 3

ANTICAVITY FLUORIDE FOAMING MOUTHWASH FOR BAD BREATH 
sodium fluoride liquid

Product Information
Item Code (Source)	NDC: 75065-012
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)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TOCOPHEROL (UNII: R0ZB2556P8)
ZINC CITRATE (UNII: K72I3DEX9B)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75065-012-03	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	06/11/2021

Part 3 of 3

MOUTH SPRAY FOR BAD BREATH 
mouthwashes and breath fresheners (liquids and sprays)

Product Information

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		20 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/28/2021

Labeler - Oral Spotlight Care Inc (117405870)