KOALA PALS BERRYLICIOUS- sodium fluoride paste, dentifrice

koala pals by

Drug Labeling and Warnings

koala pals by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc., Melaleuca, Inc._Knoxville. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Anticavity

INDICATIONS & USAGE

Use aids in the prevention of cavities

KEEP OUT OF REACH OF CHILDREN

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.

DOSAGE & 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
  

INACTIVE INGREDIENT

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

WARNINGS

Warnings

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

KOALA PALS  BERRYLICIOUS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54473-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.2592 g  in 108 g

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54473-300-04	108 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/01/2010

Labeler - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc._Knoxville		805617610	manufacture(54473-300)