SHOPKINS BRUSH BUDDIES- sodium fluoride paste 
Foshan Nanhai JiaChun Biology Engeneering 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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Anticavity

Keep out of reach of children. In case of accidental digestion seek professional assistance or contact a poison control center immediately.

Active Ingredient Purpose

Sodium Fluoride 0.243% (0.15% w/v fluoride ion) ......................... Anticavity

Helps protect teeth and roots against cavities

keep out of reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately

Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD & C Blue #1, FD &C Red # 40

Adults and children 2 years and older:
Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
Do not swallow
To minimize swallowing use a pea-sized amount in children under 6 years of age.
Supervise children's brushing until good habits are established.
Children under 2 years of age: Ask a dentist.

label

SHOPKINS BRUSH BUDDIES 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71106-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL (UNII: S8TT5K3C8Y)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorblue (F D & C Blue #1) , red (FD &C Red #4) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71106-002-01119 g in 1 TUBE; Type 0: Not a Combination Product01/11/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/11/2017
Labeler - Foshan Nanhai JiaChun Biology Engeneering Co., Ltd (527935253)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Nanhai JiaChun Biology Engeneering Co., Ltd527935253manufacture(71106-002)

Revised: 1/2017
Document Id: 45ec8db2-c37a-3d15-e054-00144ff88e88
Set id: 45d4ab3f-fc82-5f10-e054-00144ff8d46c
Version: 3
Effective Time: 20170111
 
Foshan Nanhai JiaChun Biology Engeneering Co., Ltd