5820185 TopCare Max Str Sensitive Extra Whitening

Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antihypersensitivity

Anticavity

Uses

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

Warnings

When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

See your dentist 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 1-inch strip of the product onto a soft bristle toothbrush.

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.
Children under 12 years of age: Consult a dentist or physician.

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

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139 topcare@topco.com

www.topcarebrand.com

Carton Artwork

TOPCARE SENSITIVE EXTRA WHITENING
potassium nitrate, sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-451
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:36800-451-59	1 in 1 CARTON	01/20/2011
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M022	01/20/2011

Labeler - TOPCO Assoc. LLC (006935977)

Registrant - Lornamead Inc. (080046418)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		080046418	manufacture(36800-451)