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NDC 68368-0156-00 White Glo Charcoal Deep Stain Remover Tooth 7.6 mg/g Details

White Glo Charcoal Deep Stain Remover Tooth 7.6 mg/g

White Glo Charcoal Deep Stain Remover Tooth is a DENTAL PASTE in the HUMAN OTC DRUG category. It is labeled and distributed by Barros Laboratories Pty Limited. The primary component is SODIUM MONOFLUOROPHOSPHATE.

Product Information

NDC	68368-0156
Product ID	68368-156_bbb20b4b-d365-787b-e053-2995a90a084e
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	White Glo Charcoal Deep Stain Remover Tooth
Proprietary Name Suffix	n/a
Non-Proprietary Name	SODIUM MONOFLUOROPHOSPHATE
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE
Route	DENTAL
Active Ingredient Strength	7.6
Active Ingredient Units	mg/g
Substance Name	SODIUM MONOFLUOROPHOSPHATE
Labeler Name	Barros Laboratories Pty Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part355
Listing Certified Through	n/a

Package

Package Images

NDC 68368-0156-00 (68368015600)

Pricing Information	N/A
NDC Package Code	68368-156-00
Billing NDC	68368015600
Package	1 TUBE in 1 PACKAGE (68368-156-00) / 150 g in 1 TUBE
Marketing Start Date	2018-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a514d6d3-7c03-4377-b5cb-af5aadfcd291 Details

DRUG FACTS

Active ingredient

Sodium Monoflourophosphate 0.76%

Purpose

Anticavity toothpaste

Use

helps protect against cavities

Warnings

Keep out of 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

adult and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
do not swallow
to minimize swallowing use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 years: ask a dentist.

Inactive ingredients:

Calcium Carbonate, Aqua (Water), Glycerin, Sorbitol, Silica, Aroma (Flavor), Sodium Lauryl Sulphate, Carboxymethyl Hydroxyethylcellulose, Chondrus Crispus (Carrageenan), Charcoal Powder, CI 77891 (Titanium Dioxide), Sodium Saccharin, Rosa Canina Fruit Oil.

Package Labeling

INGREDIENTS AND APPEARANCE

WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH

sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68368-156
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68368-156-00	1 in 1 PACKAGE	02/01/2018	12/01/2023
1		150 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	02/01/2018	12/01/2023

Labeler - Barros Laboratories Pty Limited (751813452)

Revised: 2/2021

Document Id: bbb20b4b-d365-787b-e053-2995a90a084e

Set id: a514d6d3-7c03-4377-b5cb-af5aadfcd291

Version: 2

Effective Time: 20210219