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NDC 72135-0033-01 Murchison Hume Dental Kit Details

Murchison Hume Dental Kit

Murchison Hume Dental Kit is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Luoding Quality Amenities Supply Limited. The primary component is .

Product Information

NDC	72135-0033
Product ID	72135-033_ed9b00de-1e0c-4821-e053-2a95a90a9a82
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	Murchison Hume Dental 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	Luoding Quality Amenities Supply Limited
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 72135-0033-01 (72135003301)

Pricing Information	N/A
NDC Package Code	72135-033-01
Billing NDC	72135003301
Package	1 KIT in 1 KIT (72135-033-01) * 10 g in 1 TUBE (72135-032-01)
Marketing Start Date	2020-10-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b077e581-67e3-5e1f-e053-2a95a90a353b Details

Drug Facts

Active ingredient

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

Purpose

Anticavity

Indication

Aids in the prevention of dental 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 brushing and rinsing (Do not swallow)
children under 2 years	ask a dentist or physician

Non medicinal 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

Package Labeling:72135-032-01

INGREDIENTS AND APPEARANCE

MURCHISON HUME DENTAL KIT

sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72135-033

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72135-033-01	1 in 1 KIT	10/12/2020

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	10 g

Part 1 of 1
COLGATE ANTICAVITY sodium monofluorophosphate paste

Product Information
Item Code (Source)	NDC:72135-032
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72135-032-01	10 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	10/12/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/12/2020

Labeler - Luoding Quality Amenities Supply Limited (528126807)

Name	Address	ID/FEI	Business Operations
Establishment
Luoding Quality Amenities Supply Limited		528126807	manufacture(72135-033)

Revised: 11/2022

Document Id: ed9b00de-1e0c-4821-e053-2a95a90a9a82

Set id: b077e581-67e3-5e1f-e053-2a95a90a353b

Version: 3

Effective Time: 20221116