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Colgate

Dosage form: paste
Ingredients: SODIUM FLUORIDE 1.5mg in 1g
Labeler: Buzz Export Services Pty., Ltd.
NDC Code: 69491-060

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.

DENTAL KITS - COLGATE TOOTHPASTE

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 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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician


children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)


children under 2 years: ask a dentist or physician

Inactive Ingredients

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

Questions?

1-800-468-6502

Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022

DRUG FACTS PANEL INSERT

DENTAL KIT - COLGATE TOOTHPASTE 5g Labels

TUBE LABELING:

KIT PACKAGING:

DENTAL KIT - COLGATE TOOTHPASTE 10g

TUBE LABELING:

KIT PACKAGING:

COLGATE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-060(NDC:42555-060)
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
WATER 
SORBITOL 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:69491-060-451 TUBE in 1 BAG
15 g in 1 TUBE
2NDC:69491-060-941 TUBE in 1 BAG
210 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/03/2014
Labeler - Buzz Export Services Pty., Ltd. (747317902)
Establishment
NameAddressID/FEIOperations
Hangzhou Zhuwen Inflight & Travel Products Co., Ltd.421290194repack(69491-060)

Revised: 07/2015
 
Buzz Export Services Pty., Ltd.

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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