White Glo Charcoal Sensitive Toothpaste Kit

White Glo Charcoal Sensitive Toothpaste Kit
SPL v6
SPL
SPL Set ID a5edb7fd-c637-5447-e053-2995a90a5a6f
Route
DENTAL
Published
Effective Date 2020-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion
Inactive Ingredients
Sorbitol Hydrated Silica Sodium Lauryl Sulfate Glycerin Water Carboxymethylcellulose Sodium, Unspecified Form Chondrus Crispus Carrageenan Saccharin Sodium Sodium Benzoate Activated Charcoal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-16

Description

Potassium nitrate 5% Sodium monofluorophospahte 0.76% (0.1% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

Potassium nitrate 5% Sodium monofluorophospahte 0.76% (0.1% w/v fluoride ion)

Uses

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

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.





Drug Facts

Other Information

• store below 30ºC (86ºF)

Package Labeling:

Active Ingredients

Potassium nitrate 5%

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

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: [email protected] White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

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.


Structured Label Content

Uses

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

Purpose

Antihypersensitivity

Anticavity

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.





Drug Facts

Other Information (Other information)

• store below 30ºC (86ºF)

Package Labeling:

Active Ingredients (Active ingredients)

Potassium nitrate 5%

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

Inactive Ingredients (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? (Questions or comments?)

For customer enquiries, please contact: [email protected] White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

When Using This Product, (When using this product,)

if irritation occurs discontinue use.

Stop Use and Ask A Dentist If (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. (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.


Advanced Ingredient Data


Raw Label Data

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