COLGATE ENAMEL HEALTH WHITENING- sodium fluoride paste, dentifrice
Colgate-Palmolive Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Enamel Health™ Whitening

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, glycerin, PEG-12, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, microcrystalline cellulose, zinc phosphate tetrahydrate, cellulose gum, cocamidopropyl betaine, sodium saccharin, xanthan gum, mica, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

STRENGTHEN & REPLENISH

✓: STRENGTHENS ENAMEL 4X BETTER†
✓: HELPS REPLENISH NATURAL CALCIUM

ENAMEL
HEALTH

WHITENING

NET WT 6.0 OZ (170 g)
CLEAN MINT paste

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

COLGATE ENAMEL HEALTH WHITENING
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-205
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
ZINC PHOSPHATE TETRAHYDRATE (UNII: 54S8C1184Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35000-205-20	1 in 1 CARTON	02/09/2015	12/30/2023
1		24 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:35000-205-23	1 in 1 CARTON	07/07/2014	12/30/2023
2		65 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:35000-205-69	1 in 1 CARTON	06/17/2014	12/30/2023
3		113 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC:35000-205-26	1 in 1 CARTON	06/17/2014	12/30/2023
4		155 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC:35000-205-85	1 in 1 CARTON	07/23/2014	12/30/2023
5		204 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC:35000-205-18	1 in 1 CARTON	07/07/2016	12/30/2023
6		51 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC:35000-205-04	2 in 1 CARTON	06/17/2014	06/17/2014
7		113 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC:35000-205-60	1 in 1 CARTON	11/30/2017	12/30/2023
8		170 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC:35000-205-33	1 in 1 CARTON	12/12/2019	12/30/2023
9		36.8 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC:35000-205-34	2 in 1 CARTON	12/12/2019	12/30/2023
10		170 g in 1 TUBE; Type 0: Not a Combination Product
11	NDC:35000-205-02	1 in 1 CARTON	02/20/2020	12/30/2023
11		56.6 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC:35000-205-21	1 in 1 CARTON	04/23/2021	12/30/2023
12		59 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 FINAL	part355	06/17/2014	12/30/2023

Labeler - Colgate-Palmolive Company (001344381)

Name	Address	ID/FEI	Business Operations
Establishment
Colgate-Palmolive Company		785047999	ANALYSIS(35000-205) , LABEL(35000-205) , MANUFACTURE(35000-205) , PACK(35000-205)

Revised: 9/2022

Document Id: f7b6d01b-1c51-48f6-9a6e-49d19a0c25d6

Set id: 6b427dae-9388-45df-8f8e-09fb66cbf1d3

Version: 12

Effective Time: 20220920

Colgate-Palmolive Company