DailyMed - WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

NDC Code(s): 73656-030-00, 73656-031-00
Packager: WHITE GLO USA INC

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated February 26, 2025

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Drug Facts

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Active ingredient
Sodium monofluorophosphate 0.76% (0.1% W/W fluoride ion). Purpose - Anticavity toothpaste

Sodium monofluorophosphate 0.76% (0.1% W/W fluoride ion).

Purpose

Anticavity toothpaste

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Use
helps protect against cavities

helps protect against cavities
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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.

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.

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Directions

Adults and children - 2 years of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children ...

Other information
Store in a cool place, below 86° F, away from heat - Do not use if quality seal is broken or missing
- Store in a cool place, below 86° F, away from heat
- Do not use if quality seal is broken or missing
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Inactive ingredients
Calcium Carbonate, Aqua (Water), Glycerin, Sorbitol, Silica, Aroma (Flavour), Sodium Lauryl Sulphate, Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hydroxyethyl-cellulose, Chondrus Crispus ...

Calcium Carbonate, Aqua (Water), Glycerin, Sorbitol, Silica, Aroma (Flavour), Sodium Lauryl Sulphate, Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hydroxyethyl-cellulose, Chondrus Crispus (Carrageenan), Sodium Saccharin, Rosa Canina Fruit Oil, CI 77891.
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Questions or comments
For customer enquiries, please contact: smiles@whiteglo.com www.whiteglo.com

For customer enquiries, please contact: smiles@whiteglo.com www.whiteglo.com
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Package Labeling:
...

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Adults and children 2 years of age & older:	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age:	Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

INGREDIENTS AND APPEARANCE

Product Information

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-030

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-030-00	1 in 1 KIT	09/01/2024

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	150 g

Part 1 of 1

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:73656-031
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)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

#	Item Code	Package Description
Packaging
1	NDC:73656-031-00	1 in 1 BOX
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 Drug	M021	09/01/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	09/01/2024

Labeler - WHITE GLO USA INC (117345666)

Name	Address	ID/FEI	Business Operations
Establishment
Suzhou Baozi Healthy Technology Co.,Ltd		529638300	manufacture(73656-031)

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Published Date (What is this?)	Version	Files
Feb 28, 2025	3 (current)	download
Jan 22, 2025	2	download
Dec 30, 2024	1	download

	RxCUI	RxNorm NAME	RxTTY
1	545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN
2	545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD
3	545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY
4	545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY
5	545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY
6	545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY

Label: WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

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Purpose

Keep out of reach of children under 6 years of age.

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	NDC
1	73656-030-00
2	73656-031-00

Label: WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

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Drug Label Info

Safety

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More Info For This Drug

Drug Label Information

Purpose

Keep out of reach of children under 6 years of age.

Find additional resources

Safety

Related Resources

More Info on this Drug

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

Number of versions: 3

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

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WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.