COLGATE KIDS WATERMELON FLAVOR- sodium fluoride gel, dentifrice

COLGATE KIDS WATERMELON FLAVOR by

Drug Labeling and Warnings

COLGATE KIDS WATERMELON FLAVOR 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

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, glycerin, hydrated silica, PEG-12, sodium lauryl sulfate, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, flavor, xanthan gum, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

2 in 1
Toothpaste
& Mouthwash

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity and Enamel Protection

WATERMELON FLAVOR

NET WT 4.6 OZ (130 g) LIQUID GEL

INGREDIENTS AND APPEARANCE

COLGATE KIDS WATERMELON FLAVOR 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-905
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	646.15 mg  in 1 g
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-905-81	130 g in 1 BOTTLE; Type 0: Not a Combination Product	07/26/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/26/2011

Labeler - Colgate-Palmolive Company (001344381)