Skip to Content

Colgate

Medically reviewed on Jul 23, 2018

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)

 
Buzz Export Services Pty., Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide