DELTA PREMIUM SELECT 2019 TUMI MORRISON AMENITY WITH COLGATE CAVITY PROTECTION- sodium monofluorophosphate 
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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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DELTA PREMIUM SELECT 2019 - TUMI MORRISON - AMENITY KIT With Colgate Cavity Protection 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 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 apea 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?

1-800-492-7378

DELTA PREMIUM SELECT 2019 - TUMI MORRISON - AMENITY KIT With Colgate Cavity Protection Toothpaste (69491-205-00)

Kit

COLGATE ANTICAVITY 5g (42555-060-94)

LabelPasteBrush

DELTA PREMIUM SELECT 2019 TUMI MORRISON AMENITY WITH COLGATE CAVITY PROTECTION 
sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-205
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-205-001 in 1 KIT04/01/2019
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 ION7.6 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)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
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 finalpart35504/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/2019
Labeler - Buzz Export Services Pty., Ltd. (747317902)

Revised: 12/2021
Document Id: d42248c5-316c-6798-e053-2995a90a81cd
Set id: 0f6d023b-8ef4-4045-a945-28420c7d5c2e
Version: 3
Effective Time: 20211227
 
Buzz Export Services Pty., Ltd.