Koala Pals Tooth Gel +fluoride Berrylicious

Koala Pals Tooth Gel +fluoride Berrylicious
SPL v3
SPL
SPL Set ID 6624be86-c9a8-53b8-e053-2a91aa0a87ef
Route
TOPICAL
Published
Effective Date 2011-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.2592 g)
Inactive Ingredients
Anhydrous Citric Acid Acesulfame Potassium Glycerin Hydrated Silica Potassium Sorbate Sodium Benzoate Sodium Bicarbonate Sodium Lauroyl Sarcosinate Sorbitol Water Xanthan Gum Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-01

Description

Active ingredient Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use aids in the prevention of cavities

Dosage and Administration

Directions

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal, or at least twice a day or as directed by a dentist or doctor
  • children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
  • children under 2 years of age: ask a dentist or doctor

Description

Active ingredient Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)

Section 50565-1

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol

Section 51945-4
Section 55105-1

Purpose

Anticavity

Section 55106-9

Active ingredient

Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)


Structured Label Content

Indications and Usage (34067-9)

Use aids in the prevention of cavities

Dosage and Administration (34068-7)

Directions

  • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal, or at least twice a day or as directed by a dentist or doctor
  • children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
  • children under 2 years of age: ask a dentist or doctor

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

Warnings

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients acesulfame potassium, citric acid, flavor, glycerin, hydrated silica, natural lemon and orange flavor extracts, potassium sorbate, sodium benzoate, sodium bicarbonate, sodium lauroyl sarcosinate, sorbitol, water, xanthan gum, xylitol

Section 51945-4 (51945-4)
Section 55105-1 (55105-1)

Purpose

Anticavity

Section 55106-9 (55106-9)

Active ingredient

Sodium Fluoride 0.24% (fluoride ion 0.15% w/v)


Advanced Ingredient Data


Raw Label Data

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