COLGATE HEMP SEED OIL- sodium fluoride paste, dentifrice
Colgate-Palmolive

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.

----------

Colgate® Hemp Seed Oil

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

Sorbitol, Water, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Cannabis Sativa (Hemp) Seed Oil, Blue 1, Yellow 5.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NEW

WITH
HEMP SEED OIL
AND PEPPERMINT OIL

HERBAL MINT

NET WT
4.6 OZ (130g)

Daily toothpaste provides soothing comfort with a refreshing feeling

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

COLGATE HEMP SEED OIL
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-041
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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35000-041-46	1 in 1 CARTON	12/06/2019	12/31/2022
1		130 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	12/06/2019	12/31/2022

Labeler - Colgate-Palmolive (001344381)

Name	Address	ID/FEI	Business Operations
Establishment
Colgate-Palmolive		785047999	MANUFACTURE(35000-041)

Revised: 9/2022

Document Id: b4826b5d-1fa4-4a5d-a4eb-45312372c623

Set id: 53c40d63-9a2b-4402-a172-302a3a0556d4

Version: 9

Effective Time: 20220920

Colgate-Palmolive