Spotlight Oral Care Kit for Bad Breath

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]

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

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 Anticavity

Use Aids in the prevention of dental decay.

Warnings

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 (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 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 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? +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

BadBreath Kit Label

006 Tube

BadBreath Kit M-Wash

Spray for BadBreath

res

SPOTLIGHT ORAL CARE KIT FOR BAD BREATH 
kit for bad breath kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75065-010
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-010-051 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package06/28/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 100 g
Part 21 BOTTLE 30 mL
Part 31 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 AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-006-021 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 finalpart35506/11/2021
Part 2 of 3
ANTICAVITY FLUORIDE FOAMING MOUTHWASH FOR BAD BREATH 
sodium fluoride liquid
Product Information
Item Code (Source)NDC: 75065-012
Route of 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)  
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75065-012-0330 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 finalpart35506/11/2021
Part 3 of 3
MOUTH SPRAY FOR BAD BREATH 
mouthwashes and breath fresheners (liquids and sprays)
Product Information
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
120 mL in 1 BOTTLE, SPRAY; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/28/202112/31/2023
Labeler - Oral Spotlight Care Inc (117405870)

Revised: 1/2023