COLGATE HYDRIS DRY MOUTH- sodium fluoride gel, dentifrice

Colgate Hydris Dry Mouth by

Drug Labeling and Warnings

Colgate Hydris Dry Mouth by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, hydrogenated coconut oil, sodium lauryl sulfate, flavor, cellulose gum, sodium saccharin, tetrasodium pyrophosphate, cocamidopropyl betaine, FD&C blue no. 1

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

NEW

Colgate®

Anticavity Fluoride Toothpaste

• Soothes mouth dryness
• Helps prevent cavities
• Freshens breath

Hydris™
DRY MOUTH

LOCKS IN A HYDRATED FEELING
4 HOURS OF LASTING COMFORT

NET WT 4.2 OZ (119 g)

#1
COLGATE:
DENTIST RECOMMENDED
ORAL CARE BRAND

HYDRAMINT™
gel

INGREDIENTS AND APPEARANCE

COLGATE HYDRIS DRY MOUTH 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-210
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	GREEN (Light green)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-210-71	1 in 1 CARTON	12/01/2017	01/01/2022
1		119 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 FINAL	part355	12/01/2017

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-210)