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koala pals

Melaleuca, Inc.

KP Fluoride Tooth Gel Content of Label




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

Purpose
Anticavity

Uses

Use aids in the prevention of cavities

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.

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 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

koala pals

Warnings

koala pals

Sodium Fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-204
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.2592 g

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
GLYCERIN
HYDRATED SILICA
POTASSIUM SORBATE
SODIUM BENZOATE
SODIUM BICARBONATE
SODIUM LAUROYL SARCOSINATE
sorbitol
water
XANTHAN GUM
Xylitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54473-204-04 108 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2010-04-01


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Be sure to consult your doctor before taking any medication!
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