DENTAL GUARDIAN- sodium monofluorophosphate paste, dentifrice 
Sungwon Pharmaceutical 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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76058-103 De-activation

SODIUM MONOFLUOROPHOSPHATE 0.69%

Anticavity

Keep out of reach of children.

Keep out of reach of Children.

Direction
Adult - brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

Brush teeth thoroughly, preferably after each meal


Lonicera Dasystyla Flower Bud
Bee pollen
Propolis wax
Silicon Dioxide
Sodium Chloride
Steviol
Xylitol
Aloe
Angelica archangelica leaf
Actaea cimicifuga root
Sorbitol
Levomenthol
Ascorbic acid
Angelica dahurica root
Erythritol

image description

DENTAL GUARDIAN 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76058-103
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION172 mg  in 25 g
Inactive Ingredients
Ingredient NameStrength
LONICERA DASYSTYLA FLOWER BUD (UNII: J133K038DY)  
BEE POLLEN (UNII: 3729L8MA2C)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
STEVIOL (UNII: 4741LYX6RT)  
XYLITOL (UNII: VCQ006KQ1E)  
ALOE (UNII: V5VD430YW9)  
ANGELICA ARCHANGELICA LEAF (UNII: 7RKK4V8HKA)  
ACTAEA CIMICIFUGA ROOT (UNII: 65J267BAZT)  
SORBITOL (UNII: 506T60A25R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)  
ERYTHRITOL (UNII: RA96B954X6)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76058-103-021 in 1 CARTON06/02/201104/01/2019
1NDC:76058-103-0125 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/02/201104/01/2019
Labeler - Sungwon Pharmaceutical Co., Ltd. (689787898)
Registrant - Sungwon Pharmaceutical Co., Ltd. (689787898)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(76058-103)

Revised: 4/2019
Document Id: 857c6832-daeb-4b80-e053-2a91aa0a3c77
Set id: 29223747-5e78-4a4c-a0ed-13f2d3346b56
Version: 9
Effective Time: 20190401
 
Sungwon Pharmaceutical Co., Ltd.