Colgate Kids Hum Mild Bubble Fruit Flavor: Package Insert and Label Information

COLGATE KIDS HUM MILD BUBBLE FRUIT FLAVOR- sodium fluoride gel, dentifrice
Colgate-Palmolive Company

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.

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, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Questions?

1-833-HUM-0001

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

PRINCIPAL DISPLAY PANEL — 124 g Tube Label

hum®

kids
inspired by
little smiles.

maximum cavity
protection*

Colgate®

mild
bubble fruit®

Anticavity Fluoride
Toothpaste

ADA
Accepted
American
Dental
Association ®

NET WT
4.4 OZ (124 g)

PRINCIPAL DISPLAY PANEL -- 124 g Tube Label
(click image for full-size original)
COLGATE KIDS HUM MILD BUBBLE FRUIT FLAVOR
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:35000-198
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL 476 mg in 1 g
WATER
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
SODIUM LAURYL SULFATE
SACCHARIN SODIUM
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color GREEN Score
Shape Size
Flavor FRUIT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35000-198-44 124 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 11/01/2021
Labeler — Colgate-Palmolive Company (001344381)

Revised: 11/2021 Colgate-Palmolive Company

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