bite toothpaste fluoride toothpaste bits

bite toothpaste fluoride toothpaste bits
SPL v4
SPL
SPL Set ID eedf13dc-a009-027a-e053-2995a90a8ec8
Route
dental
Published
Effective Date 2022-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.76 g)
Inactive Ingredients
xylitol menthol silicon dioxide sodium cocoyl glutamate calcium carbonate peppermint sodium bicarbonate zinc citrate starch, corn magnesium stearate guar gum

Identifiers & Packaging

Pill Appearance
Imprint: B Shape: round Color: white Size: 6 mm
Marketing Status
otc monograph drug active Since 2022-12-06

Description

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)


Medication Information

Warnings and Precautions

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

Active Ingredient

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)

Indications and Usage

Helps protect against dental cavities

Dosage and Administration

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or atleast twice daily or as directed by a dentist or physician. Rinse after using. Do not swallow.

Description

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)

Section 50565-1

Keep out of reach of children under 6 yrs of age

Section 51727-6

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

Section 51945-4

Section 53413-1

BiteToothpaste.com

Section 55105-1

Anticavity

Section 60561-8

Store at room temperature and in a dry place.


Structured Label Content

Warnings and Precautions (34071-1)

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

Active Ingredient (55106-9)

Sodium Monofluorophosphate 0.76 % (0.14% w/w fluoride ion)

Indications and Usage (34067-9)

Helps protect against dental cavities

Dosage and Administration (34068-7)

Adult:

Wet your toothbrush and place one (1) toothpaste bit in your mouth and bite down. Brush teeth thoroughly preferably after each meal or atleast twice daily or as directed by a dentist or physician. Rinse after using. Do not swallow.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 yrs of age

Section 51727-6 (51727-6)

Calcium Carbonate, Colloidal Silicon Dioxide, Guar Gum, Magnesium Stearate, Menthol, Natural Flavor (Peppermint), Sodium Bicarbonate, Sodium Cocoyl Glutamate, Starch, Xylitol, Zinc Citrate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

BiteToothpaste.com

Section 55105-1 (55105-1)

Anticavity

Section 60561-8 (60561-8)

Store at room temperature and in a dry place.


Advanced Ingredient Data


Raw Label Data

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