DELTA COMFORT AMENITY- sodium monofluorophosphate 
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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DELTA COMFORT + Amenity Kit

Drug Fact

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, aqua(water), sorbitol, sodium lauryl sulfate, aroma(flavour,) cellulose gum, tetrasodium pyrophosphate, sodium saccharinm limonene

Questions or comments?

Call to-free 1-800-468-6502

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DELTA COMFORT AMENITY 
sodium monofluorophosphate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69491-100
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-100-001 in 1 KIT06/01/201812/18/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 5 g
Part 1 of 1
COLGATE 
sodium fluoride paste
Product Information
Item 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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69491-060-451 in 1 CARTON
15 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart355B06/01/201812/18/2018
Labeler - Buzz Export Services Pty Ltd (747317902)

Revised: 12/2019
 
Buzz Export Services Pty Ltd