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Care One

AMERICAN SALES
Lornamead

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients / Purpose

Potassium nitrate 5%....................................................Antihypersensitivity

Sodium fluoride 0.24% (0.15% w/v fluoride ion)............Anticavity

Care One Uses

aids in the prevention of dental cavities

If pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and see your doctor if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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

Directions

Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Children under 12 years of age: consult a dentist or a doctor.

Other Information

Store in a cool dry place. Keep tube capped when not in use.

Inactive ingredients

cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

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Care One

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Care One

Care One

Fluoride PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:41520-111
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.24 g
POTASSIUM NITRATE NITRATE ION 5.0 g

Inactive Ingredients

Ingredient Name Strength
water
saccharin sodium
SODIUM TRIPOLYPHOSPHATE
polyethylene glycol 400
sorbitol
titanium dioxide
SODIUM HYDROXIDE
GLYCERIN
XANTHAN GUM
HYDRATED SILICA
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-111-12 113 in 1 TUBE
2 NDC:41520-111-19 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2011-01-20


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Be sure to consult your doctor before taking any medication!
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