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Colgate Anticavity by Zhuhai Jenny's Choice Manufacturing Limited

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 1.5mg in 1g
Labeler: Zhuhai Jenny's Choice Manufacturing Limited
NDC Code: 69223-000

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.

Toothbrush / Colgate Fluoride Toothpaste Dental Kit

Toothbrush / Colgate Fluoride Toothpaste Dental Kit

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Toothbrush / Colgate Fluoride Toothpaste Dental Kit 10g (69223-000-00)

COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69223-000(NDC:42555-060)
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (fluoride Ion) fluoride Ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
WATER 
SORBITOL 
SODIUM LAURYL SULFATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:69223-000-001 TUBE (TUBE) in 1 PACKAGE
110 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/22/2014
Labeler - Zhuhai Jenny's Choice Manufacturing Limited (421185936)
Establishment
NameAddressID/FEIOperations
Colgate-Palmolive (Thailand) Limited - Branch672044552manufacture(69223-000)
Establishment
NameAddressID/FEIOperations
Zhuhai Jenny's Choice Manufacturing Limited421185936relabel(69223-000), repack(69223-000)

Revised: 09/2014
 
Zhuhai Jenny's Choice Manufacturing Limited

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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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