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NDC 42555-0000-01 5g Colgate plus Toothbrush Kit Details

5g Colgate plus Toothbrush Kit

5g Colgate plus Toothbrush Kit is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Colgate-Palmolive (Thailand) Limited - Branch. The primary component is .

Product Information

NDC	42555-0000
Product ID	42555-000_ed9a4454-8367-52ea-e053-2a95a90aa389
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	5g Colgate plus Toothbrush Kit
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM MONOFLUOROPHOSPHATE
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Colgate-Palmolive (Thailand) Limited - Branch
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	2023-12-31

Package

Package Images

NDC 42555-0000-01 (42555000001)

Pricing Information	N/A
NDC Package Code	42555-000-01
Billing NDC	42555000001
Package	1 KIT in 1 KIT (42555-000-01) * 5 g in 1 TUBE (42555-060-94)
Marketing Start Date	2018-06-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fcb1916a-883a-4611-a253-efd880bc5ae1 Details

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 to-free 1-800-468-6502

Package Labeling:

INGREDIENTS AND APPEARANCE

5G COLGATE PLUS TOOTHBRUSH KIT

sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42555-000

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42555-000-01	1 in 1 KIT	06/07/2018

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	5 g

Part 1 of 1
COLGATE ANTICAVITY sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:42555-060
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42555-060-94	5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/07/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/07/2018

Labeler - Colgate-Palmolive (Thailand) Limited - Branch (672044552)

Name	Address	ID/FEI	Business Operations
Establishment
Luoding Quality Amenities Supply Limited		528126807	manufacture(42555-000)

Revised: 11/2022

Document Id: ed9a4454-8367-52ea-e053-2a95a90aa389

Set id: fcb1916a-883a-4611-a253-efd880bc5ae1

Version: 6

Effective Time: 20221116