COLGATE- sodium fluoride paste 
Buzz Export Services Pty., 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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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

DRUG FACTS PANEL

DENTAL KIT - COLGATE TOOTHPASTE 5g Labels

TUBE LABELING:

Colgate5g1

KIT PACKAGING:

KIT PACKAGING 5G

DENTAL KIT - COLGATE TOOTHPASTE 10g

TUBE LABELING:

Colgate10g1

KIT PACKAGING:

KIT PACKAGING 10G

COLGATE 
sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-060-451 in 1 BAG12/03/2014
15 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69491-060-941 in 1 CARTON12/03/2014
210 g in 1 TUBE; Type 0: Not a Combination Product
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/FEIBusiness Operations
Zhejiang Baron Travel Product Co., Ltd.554520509repack(69491-060)

Revised: 12/2021
Document Id: d421cf44-3065-b927-e053-2995a90ae1b7
Set id: f84217da-dc78-4181-9fcc-6b11e92276ff
Version: 6
Effective Time: 20211227
 
Buzz Export Services Pty., Ltd.