RITE AID  ENAMEL GUARD- fluoride paste, dentifrice 
Rite Aid

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rite Aid Enamel Guard

Drug Facts

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.15% w/v fluoride ion

Purpose

Antihypersensitivity

Anticavity

Uses

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.

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.

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

Store in a cool, dry place.

DISTRIBUTED BY:

RITE AID, 30 HUNTER LANE

CAMP HILL, PA 17011

MADE IN USA

RITE AID® PHARMACY

oral care

enamel guard

gentle whitening for sensitive teeth

alpine mint

NET WT 4 OZ (113 g)

MM1

RITE AID   ENAMEL GUARD
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6020
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
POTASSIUM NITRITE (UNII: 794654G42L) (NITRITE ION - UNII:J39976L608) POTASSIUM NITRITE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6020-91 in 1 CARTON06/03/2013
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/03/2013
Labeler - Rite Aid (014578892)
Registrant - Lornamead (080046418)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead080046418manufacture(11822-6020)

Revised: 1/2023
Document Id: f20069dc-f963-2602-e053-2995a90a39e1
Set id: 67c1fc04-0f21-4944-8b9d-0d8ffd051874
Version: 20
Effective Time: 20230111
 
Rite Aid