RITE AID ENAMEL GUARD- fluoride paste, dentifrice

Rite Aid by

Drug Labeling and Warnings

Rite Aid by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

PURPOSE

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

Uses

• aids in the prevention of dental caviites
• aids in reducing sensitivity

WARNINGS

Warnings

If pain/sensitivity 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.

DOSAGE & ADMINISTRATION

Directions

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbruch.

• Brush teeth thorughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as directed by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
• Children under 12 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

Inactive ingredients water, hydrated silica, sorbitol, glycerin, PEG-8, cocamidpropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

STORAGE AND HANDLING

Store in a cool, dry place.

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DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN USA

PRINCIPAL DISPLAY PANEL

RITE AID® PHARMACY

oral care

enamel guard

gentle whitening for sensitive teeth

alpine mint

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

RITE AID  ENAMEL GUARD
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6020
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608)	POTASSIUM NITRITE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6020-9	1 in 1 CARTON	06/03/2013
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	06/03/2013

Labeler - Rite Aid (014578892)

Registrant - Lornamead (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		078584069	manufacture(11822-6020)