WALGREENS SENSITIVE EXTRA WHITENING- sodium fluoride paste, dentifrice

Walgreens Sensitive Extra Whitening by

Drug Labeling and Warnings

Walgreens Sensitive Extra Whitening by is a Otc medication manufactured, distributed, or labeled by Walgreens, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Potassium Nitrate 5% Antihypersensitivity

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

INACTIVE INGREDIENT

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

KEEP OUT OF REACH OF CHILDREN

Kep out of reach of children. If more tahn used for brushing is accidentally swallowed, get medical help or contact a poisoin control center right away.

WARNINGS

When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use.

DOSAGE & ADMINISTRATION

Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities.

INDICATIONS & USAGE

Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute twice a day (morning and evening), and not more than 3 time a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: consult a dentist or doctor.

PURPOSE

Store below 30C (86F).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS SENSITIVE EXTRA WHITENING 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-1588
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

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: 0363-1588-09	1 in 1 BOX	10/28/2022
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 Drug	M022	10/28/2022

Labeler - Walgreens (008965063)

Registrant - Lornamead Products (119559733)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Products		119559733	manufacture(0363-1588) , pack(0363-1588)