Drug Facts

Active ingredients

Potassium nitrate 5%

Sodium monofluorophospahte 0.76% (0.1% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

• Builds increasing protection against: painful sensitivity of the teeth to cold, heat, acids, sweets or contact. • Aids in the prevention of dental cavities.

Warnings

When using this product,

if irritation occurs discontinue use.

Stop use and ask a dentist if

• the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. • pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 12 years of age and older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush. • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. • Children under 12 years of age: Consult a dentist or doctor.

Other information

• store below 30ºC (86ºF)

Inactive ingredients

Sorbitol, hydrated silica, sodium lauryl sulfate, glycerin, water, cellulose gum, chondrus crispus (carrageenan), tetrasodium phosphate, sodium saccharin, sodium benzoate, bamboo charcoal

Questions or comments?

For customer enquiries, please contact: customer.enquiry@whiteglo.com White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

Package Labeling:

Label

WHITE GLO CHARCOAL SENSITIVE
potassium nitrate, sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-011

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-011-00	1 in 1 KIT	03/16/2020

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

Part 1 of 1

WHITE GLO CHARCOAL SENSITIVE
potassium nitrate, sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:73656-012
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg in 1 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)

#	Item Code	Package Description
Packaging
1	NDC:73656-012-00	1 in 1 TUBE
1		150 g in 1 BOX; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	03/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	03/16/2020

Labeler - WHITE GLO USA INC (117345666)

WHITE GLO CHARCOAL SENSITIVE TOOTHPASTE Kit