ADVANCED WHITENING ANTI CAVITY FLUORIDE- sodium fluoride paste 
Universal Distribution Center LLC

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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ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

Active Ingredient

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Warning

When using this product

Stop and ask a dentist

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

Directions

Adults and Children 12 years of age and older:

Children under 12 years of age: Consult a dentist or doctor.

Other information

Inactive Ingredients

calcium carbonate, FD&C blue#1, flavor, methylparaben, poly ethylene glycol 400, propylparaben, sodium carboxymethyl cellulose, sodium lauryl sulfate, sodium saccharin, sodium silicate, sorbitol, precipited silica, tetra sodium pyrophosphate, titanium dioxide, water.

PRINCIPAL DISPLAY PANEL

ADVANCED WHITENING ANTI-CAVITY FLUORIDE TOOTHPASTE

label

ADVANCED WHITENING ANTI CAVITY FLUORIDE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-035
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM CARBONATE (UNII: H0G9379FGK)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-035-461 in 1 BOX06/21/2017
1181 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/21/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Holyshine Industrial Co. Ltd421141948manufacture(52000-035)

Revised: 6/2017
Document Id: 527c64a8-4a3b-3ebd-e054-00144ff88e88
Set id: 591ac8f2-024a-4714-8a7b-eb8dc3bea528
Version: 1
Effective Time: 20170621
 
Universal Distribution Center LLC