COLGATE SENSITIVE COMPLETE PROTECTION- potassium nitrate and sodium fluoride paste, dentifrice

Colgate Sensitive Complete Protection by

Drug Labeling and Warnings

Colgate Sensitive Complete Protection by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion)	Anticavity

Use

• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
• helps protect against cavities

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

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.

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 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
• children under 12 years: consult a dentist or physician

Inactive ingredients

Water, Glycerin, Hydrated Silica, Sorbitol, PEG-12, Tetrapotassium Pyrophosphate, PVM/MA Copolymer, Flavor, Sodium Lauryl Sulfate, Poloxamer 407, Sodium Hydroxide, Sodium Saccharin, Cellulose Gum, Xanthan Gum, Titanium Dioxide

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Toothpaste for Sensitive Teeth

MAXIMUM STRENGTH*

Sensitive

COMPLETE PROTECTION

8 BENEFITS

✔SENSITIVITY ✔TARTAR ✔FRESHENS ✔CAVITIES
✔ENAMEL ✔PLAQUE† ✔WHITENS ✔GUMS†

NET WT 6.0 OZ (170 g)

MINT CLEAN paste

INGREDIENTS AND APPEARANCE

COLGATE SENSITIVE COMPLETE PROTECTION 
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-024
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 35000-024-60	1 in 1 CARTON	02/25/2019
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-024-34	2 in 1 CARTON	02/25/2019
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-024-33	1 in 1 CARTON	11/13/2018
3		36.8 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 NOT FINAL	part356	11/13/2018

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-024)