Wakefernenamel guard paste, dentifrice

Active ingredients

Potassium Nitrate 5%......................................................................Antihypersensitivity

Sodium Fluoride 0.15% w/v fluoride ion...........................................Anticavity

Uses

aids in the prevention of dental caviites

aids in reducing sensitivity

Warnings section

If pain/sensitivity persistsafter 4 weeks of use, please visit your dentist.

Stop use and see your doctorif the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. 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. 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.

Other information

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

Inactive ingredients

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

Dosage & administration section

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

Ingredients and appearance - Product information

Wakefernenamel guard paste, dentifrice- Fluoride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 41190-208
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 0.15 gin 100 g
Potassium nitrite ( UNII: 794654G42L)( Nitrite ion - UNII: J39976L608 ) 5 gin 100 g

Inactive Ingredients

Ingredient Name Code
Sorbitol ( UNII: 506T60A25R)
Titanium dioxide ( UNII: 15FIX9V2JP)
Glycerin ( UNII: PDC6A3C0OX)
Saccharin sodium ( UNII: SB8ZUX40TY)
Water ( UNII: 059QF0KO0R)
Sodium hydroxide ( UNII: 55X04QC32I)
Xanthan gum ( UNII: TTV12P4NEE)
Cocamidopropyl betaine ( UNII: 5OCF3O11KX)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Hydrated silica ( UNII: Y6O7T4G8P9)

Product Characteristics

Flavor MINT Color white

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part356 USA

Labeler - Wakefern( 069722418)

Establishment

Name ID/FEI Business Operations
Wakefern 069722418 manufacture( 41190-208)

Package label.principal display panel

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