WHITE GLO CHARCOAL SENSITIVE- potassium nitrate, sodium monofluorophosphate kit

WHITE GLO CHARCOAL SENSITIVE by

Drug Labeling and Warnings

WHITE GLO CHARCOAL SENSITIVE by is a Otc medication manufactured, distributed, or labeled by WHITE GLO USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

WHITE GLO CHARCOAL SENSITIVE 
potassium nitrate, sodium monofluorophosphate kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	03/16/2020

Labeler - WHITE GLO USA INC (117345666)