Colgate

Manufacturer
Colgate-Palmolive Company
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:55:51

Label at a glance#

ProductColgate Kids Unicorn Alcohol Free
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Dosage and administration

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of u...

Storage and handling

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervison

Children under 6 years of age: consult a dentist or doctor

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Disodium Phosphate, Potassium Sorbate, Cetylpyridinium Chloride, Sucralose, Green 3, Red 33.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

Colgate®
Anticavity Fluoride Rinse

Kids

  • Strengthens
    Enamel
  • Protects from
    Cavities
  • Cleans the
    Whole Mouth*

16.9 FL OZ
(1.05 PT) 500 mL

BUBBLE FRUIT®

IMPORTANT: Read directions for proper use

PS0029450

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN5
313029sodium fluoride 0.2 MG/ML MouthwashSCD5
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY5
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130035000985064GTIN-13: 0035000985064
EAN-13: 0035000985064
GTIN-12: 035000985064
UPC-A: 035000985064
GTIN storage (14 digits): 00035000985064
colgate-01.jpg
Data codeData Matrix0029450colgate-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-334-84Colgate Kids Unicorn Alcohol Free500 mL in 1 BOTTLERINSE5005

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-33435000-334-84

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-01-09full-release2026-06-01 00:06:53

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
ndc (package): 35000-334-84
ndc (product): 35000-334
ndc11 (package): 35000033484
spl id: 0471d13b-4002-44bb-bfdd-7fec76212280
spl set id: 133acaff-7205-80d7-e91d-3eb37087cae4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.