DELTA COMFORT PLUS 2019 AMENITY WITH COLGATE CAVITY PROTECTION- sodium monofluorophosphate

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Buzz Export Services Pty., Ltd.
Prescription type:
OTC DRUG
Therapeutic indications:
helps protect against cavities
Authorization status:
OTC monograph final
Authorization number:
42555-060-94, 69491-210-00

DELTA COMFORT PLUS 2019 AMENITY WITH COLGATE CAVITY PROTECTION-

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 PLUS 2019 - 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 COMFORT PLUS 2019 - AMENITY KIT With Colgate Cavity Protection Toothpaste

(69491-210-00)

COLGATE ANTICAVITY 5g (42555-060-94)

DELTA COMFORT PLUS 2019 AMENITY WITH COLGATE CAVITY

PROTECTION

sodium monofluorophosphate kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 49 1-210

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 49 1-210 -0 0

1 in 1 KIT

0 4/0 1/20 19

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

Part 1 of 1

COLGATE ANTICAVITY

sodium monofluorophosphate paste, dentifrice

Product Information

Ite m Code (Source )

NDC:42555-0 6 0

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of

Stre ng th

Stre ng th

SO DIUM MO NO FLUO RO PHO SPHATE (UNII: C8 10 JCZ56 Q) (FLUORIDE ION -

UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

7.6 mg

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

Buzz Export Services Pty., Ltd.

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

WATER (UNII: 0 59 QF0 KO0 R)

SO RBITO L (UNII: 50 6 T6 0 A25R)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

METHYL SALICYLATE (UNII: LAV5U50 22Y)

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

SO DIUM PYRO PHO SPHATE (UNII: O3528 6 4B8 Z)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:42555-0 6 0 -9 4

5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 4/0 1/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt355

0 4/0 1/20 19

Labeler -

Buzz Export Services Pty., Ltd. (747317902)

Revised: 2/2019

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