UNIWELL 8575 SALT- rosin powder, dentifrice 
SOLM Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Rosin

Sodium chloride

for dental care

keep out of reach of the children

use when is needed

- do not swallow when using this product

- if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

Hold 1 grams in mouth for 1~2 minutes then rinse out with water

label

UNIWELL 8575 SALT 
rosin powder, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70706-1003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIN (UNII: 88S87KL877) (ROSIN - UNII:88S87KL877) ROSIN0.332   in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70706-1003-175 g in 1 PACKAGE; Type 0: Not a Combination Product05/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/12/2016
Labeler - SOLM Co., Ltd. (689847034)
Registrant - SOLM Co., Ltd. (689847034)
Establishment
NameAddressID/FEIBusiness Operations
SOLM Co., Ltd.689847034manufacture(70706-1003)

Revised: 12/2019
Document Id: 9a567ce3-5634-6b9f-e053-2a95a90a9823
Set id: 32b2f1a2-6307-74f8-e054-00144ff8d46c
Version: 3
Effective Time: 20191222
 
SOLM Co., Ltd.