SENSITIVE TOOTH PASTE WHITENING- fluoride gel

Sensitive Tooth Paste by

Drug Labeling and Warnings

Sensitive Tooth Paste by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Lornamead, Assured Packaging Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

POTASSIUM NITRATE 5% .........................................HYPERSENSITIVITY
SODIUM FLUORIDE (0.15% W/V) FLUORIDE ION.........ANTICAVITY

Use

•  builds increasing protection against

                painful sensitivity of the teeth due to
                cold, heat, acids, sweats or contact

•  aids in the prevention of dental cavities

Uses

When using this product if irritation occurs
discontinue use

If pain/sensitivity still persists after 4 weeks
of use, please visit your dentist

Keep out of reach of children

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
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 doctor.
Make sure to brush all sensitive areas
of the teeth.Children under 12
years of age: consult a dentist or doctor.

Inactive ingredients

Inactive ingredients:
Water, Hydrated Silica, Glycerin, Sorbitol, Sodium Tripolyphosphate,
PEG-6, Flavor, Isopentane, Xanthan Gum, Chondrus Crispus (Carrageenan),
Sodium Hydroxide, Sodium Methyl Cocoyl Taurate, Cocomidopropyl Betaine,
Sodium Saccharin, Sucralose, FD C Blue 1

PRINCIPAL DISPLAY PANEL

Warnings

Flammable. Contents under pressure.Do not
puncture or incinerate container. Do not store at
temperatures above 120 F. Use only as
directed. Intentional misuse by deliberately
concentrating and inhaling the contents can
be harmful or fatal.

INGREDIENTS AND APPEARANCE

SENSITIVE TOOTH PASTE  WHITENING
fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-816
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (POTASSIUM CATION - UNII:295O53K152)	POTASSIUM NITRATE	5.0 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	24.0 g  in 100 g
WATER (UNII: 059QF0KO0R)	22.0697 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY)	0.2 g  in 100 g
SUCRALOSE (UNII: 96K6UQ3ZD4)	0.01 g  in 100 g
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)	3.0 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.0003 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	19.0 g  in 100 g
XANTHAN GUM (UNII: TTV12P4NEE)	0.7 g  in 100 g
CHONDRUS CRISPUS (UNII: OQS23HUA1X)	0.7 g  in 100 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)	19.0 g  in 100 g
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)	1.0 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	0.4 g  in 100 g
ISOPENTANE (UNII: ZH67814I0O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)	0.48 g  in 100 g
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)

Product Characteristics
Color	blue (BLUE AND GREEN)	Score
Shape		Size
Flavor	MINT (Hagelin 673902 Mint Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-816-68	12 in 1 CASE
1	NDC: 59779-816-67	121.6 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	12/13/2011

Labeler - CVS Pharmacy (062312574)

Registrant - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Assured Packaging Inc		248916165	pack