Universal Charcoal With Aloe Vera Anti-cavity Fluoride Toothpaste

Universal Charcoal With Aloe Vera Anti-cavity Fluoride Toothpaste
SPL v2
SPL
SPL Set ID 3411924d-1002-460c-83e8-c0c7fbff9ad1
Route
DENTAL
Published
Effective Date 2020-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.15 g)
Inactive Ingredients
Sorbitol Silicon Dioxide Xanthan Gum Saccharin Sodium Sodium Benzoate Sodium Lauryl Sulfate Water Activated Charcoal Polyethylene Glycol 1600 Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-25

Description

Active Ingredient Sodium Fluoride-0.32% (0.15% w/v fluride ion)


Medication Information

Warnings and Precautions

Warning

Indications and Usage

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets
  • aids in the prevention of dental cavities.
Dosage and Administration

Directions

  • adults and children 12 years of age and older
  • apply atleast 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 3 times a day, or as recommended by a 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

Description

Active Ingredient Sodium Fluoride-0.32% (0.15% w/v fluride ion)

Section 42229-5

Other information

  • store in a cool, dry place.
Section 50565-1

Keep out of reach of children

  • If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6

Inactive Ingredients

Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

Section 51945-4

PRINCIPAL DISPLAY PANEL

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1

Purpose

Anticavity

Section 55106-9

Active Ingredient

Sodium Fluoride-0.32% (0.15% w/v fluride ion)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets
  • aids in the prevention of dental cavities.
Dosage and Administration (34068-7)

Directions

  • adults and children 12 years of age and older
  • apply atleast 1-inch strip of product onto soft bristle toothbrush
  • brush teeth thoroughly for atleast 1 minute twice a day (morning and evening), and not more then 3 times a day, or as recommended by a 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

Warnings and Precautions (34071-1)

Warning

Section 42229-5 (42229-5)

Other information

  • store in a cool, dry place.
Section 50565-1 (50565-1)

Keep out of reach of children

  • If accidentally swallowed while brushing, seek professional help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)

Stop and ask a dentist

  • if the problem persists or worsens.

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Section 50567-7 (50567-7)

When using this product

  • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
Section 51727-6 (51727-6)

Inactive Ingredients

Sorbitol, Silica, Xanthan gum, Sodium saccharine, Sodium benzoate, Sodium Lauryl sulphate, Water, Flavor, Charcoal powder, poly ethylene glycol 1500, Aloe vera.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE TOOTHPASTE

Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active Ingredient

Sodium Fluoride-0.32% (0.15% w/v fluride ion)


Advanced Ingredient Data


Raw Label Data

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