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Shopkins Brush Buddies by Foshan Nanhai JiaChun Biology Engeneering Co., Ltd

Medically reviewed on January 11, 2017

Dosage form: paste
Ingredients: SODIUM FLUORIDE 2.4mg in 100g
Labeler: Foshan Nanhai JiaChun Biology Engeneering Co., Ltd
NDC Code: 71106-002

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.

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.

SHOPKINS BRUSH BUDDIES 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71106-002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION2.4 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
SORBITOL 
SILICA DIMETHYL SILYLATE 
WATER 
.ALPHA.-(.ALPHA.-AMINOPROPYL)BENZYL ALCOHOL 
POLYETHYLENE GLYCOL 1500 
XYLITOL 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
SACCHARIN SODIUM 
Product Characteristics
Colorblue (F D & C Blue #1) , red (FD &C Red #4) Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:71106-002-01119 g in 1 TUBE
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/FEIOperations
Foshan Nanhai JiaChun Biology Engeneering Co., Ltd527935253manufacture(71106-002)

 
Foshan Nanhai JiaChun Biology Engeneering Co., Ltd

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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