COLGATE 2 IN 1 KIDS SP STRAWBERRY- sodium fluoride gel, dentifrice

COLGATE 2 IN 1 KIDS SP STRAWBERRY by

Drug Labeling and Warnings

COLGATE 2 IN 1 KIDS SP STRAWBERRY by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Mission Hills, S.A. de C.V.. 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, Red 40.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

CLINICALLY
PROVEN
Cavity & Enamel
Protection

STRAWBERRY
BURST
Toothpaste

✓ LESS MESS!
✓ SUGAR FREE

LIQUID GEL
NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

COLGATE 2 IN 1 KIDS SP STRAWBERRY 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-915
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)	680 mg  in 1 g
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-915-46	130 g in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	11/01/2024

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(35000-915) , MANUFACTURE(35000-915) , PACK(35000-915) , LABEL(35000-915)