HOUSE LIVING- sodium monofluorophosphate 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 ingredients

SODIUM MONOFLUOROPHOSPHATE 0.76%

Purpose

anticavity

Uses

Regular brushing with fluoride toothpaster helps protect teeth and roots against cavities.

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidentally swalowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

Directions

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

Children under 6 years of age ,in good brushing and rinsing habits (to minimize swallowing),

supervise children as necessary until capable of useing without supervision.

Children under 2 years of age:consult a dentist or doctor.

INACTIVE INGREDIENT

Water,Silica ,Calcium Carbonate,Sodium Lauryl Alcohol,Sorbitol,Polyethylene Glycol 400, Sodium Carboxymethylcellulose,Sodium Saccharin,Sodium Hydroxide,Methyl Paraben,Propylparaben,Flavor

1

HOUSE LIVING 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71704-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SORBITOL (UNII: 506T60A25R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71704-001-0124 in 1 CARTON09/13/2017
1128 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/13/2017
Labeler - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
Registrant - Guangzhou Beauty Cosmetic Co., Ltd (528735414)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Beauty Cosmetic Co., Ltd528735414manufacture(71704-001)

Revised: 9/2017
Document Id: 58ad4ae2-6142-0eea-e053-2a91aa0aac60
Set id: 58ad4ae2-6141-0eea-e053-2a91aa0aac60
Version: 1
Effective Time: 20170908
 
Guangzhou Beauty Cosmetic Co., Ltd