HOUSE LIVING- sodium fluoride,potassium nitrate paste 
Guangzhou Beauty Cosmetic Co., Ltd

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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Active Ingredient

SODIUM FLUORIDE 0.15%

Potassium Nitrate 5%

Purpose

Antihypersensitivity

Anticavity

Use

bulids increasing protection against painful sensitivity of the teeth due to cold,heat,acids,sweets or contact

aids in the privention of dental cavities

Warning

Stop use and ask a dentist if

the problem pensists os worsens,sensitive teeth may indicate a serious problem that may prompt care by a dentist

pain/sensitivity still persists after 4 weeks of use.

Directions

Adults and children 2 years of age and older:brush teeth thoroughly, preferably after meals or at least twice a day or use as directed by a dentist or doctor.

instruct children 6 years of age in good brushing and rinsing habits(to minimize swallowing)

suprevise children as necessary untill capable of using without supervision.

children under 2 years of age :consult a dentist or doctor

Inactive Ingredients

Water,Silica (Thickening 10 & Friction 4)
,Sodium Lauryl Alcohol,Sorbitol,Polyethylene Glycol 300,Sodium Carboxymethylcellulose,Flavor,Sodium Saccharin,Titanium Dioxide,Sodium Pyrophosphate,PEG/PPG 116/66 copolymer
Sodium Hydroxide,Acid Yellow 23,Acid Blue 1

Keep out of reach of children under 6 years of age.



If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

1

HOUSE LIVING 
sodium fluoride,potassium nitrate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71704-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE DECAHYDRATE (UNII: IY3DKB96QW)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71704-002-0124 in 1 CARTON07/10/2016
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/10/2016
Labeler - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
Registrant - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Beauty Cosmetic Co., Ltd528735414manufacture(71704-002)

Revised: 9/2017
Document Id: 591356ba-34c6-dd3f-e053-2991aa0a40f6
Set id: 59130dc9-1189-6428-e053-2991aa0a4285
Version: 1
Effective Time: 20170913
 
Guangzhou Beauty Cosmetic Co., Ltd