COLGATE 5G TOOTHBRUSH KIT- sodium monofluorophosphate 
Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd.

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Colgate 5g Toothpaste + Toothbrush Kit

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental caries

Warning

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

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

Questions or comments?

1-800-468-6502

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 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, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Package Labeling:Kit

KIT Label

Package Labeling:42555-060-94

Colgate.5g

COLGATE 5G TOOTHBRUSH KIT 
sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72845-000
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72845-000-001 in 1 KIT01/19/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 5 g
Part 1 of 1
COLGATE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice
Product Information
Item Code (Source)NDC:42555-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42555-060-945 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02101/19/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02101/19/2021
Labeler - Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd. (560449103)

Revised: 10/2023
Document Id: 090d6a60-bb3f-b449-e063-6394a90a47a3
Set id: 4f0fda5e-ef42-42c3-8270-3ba614650ad1
Version: 3
Effective Time: 20231031
 
Wuhan Jinshengyuan Textiles Manufacturing Co., Ltd.