GOOD MORNING E-FRESH TOOTH- sodium monofluorophosphate paste, dentifrice 
Kumho Dental Pharm. 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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SODIUM MONOFLUOROPHOSPHATE

For dental care

Keep out of reach of children

Apply proper amount and brush teeth thoroughly

If more than used for brushing is accidentally swallowed, get medical help.

HYDRATED SILICA (DENTAL-TYPE SILICA)
SODIUM MONOFLUOROPHOSPHATE
TETRASODIUM PYROPHOSPHATE
PYRIDOXINE HCI
TOCOPHERYL ACETATE

ETC.

For dental use only

1

GOOD MORNING E-FRESH TOOTH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70452-100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70452-100-01150 g in 1 TUBE; Type 0: Not a Combination Product01/01/201802/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/201802/01/2018
Labeler - Kumho Dental Pharm. Co., Ltd. (631133766)
Registrant - Kumho Dental Pharm. Co., Ltd. (631133766)
Establishment
NameAddressID/FEIBusiness Operations
Kumho Dental Pharm Co Ltd631133766manufacture(70452-100)

Revised: 2/2018
Document Id: 65c6918f-182e-17cf-e053-2991aa0a8920
Set id: 6587ba91-891f-5d3a-e053-2a91aa0af6c2
Version: 2
Effective Time: 20180222
 
Kumho Dental Pharm. Co., Ltd.