COLGATE KIDS LLAMA MILD BUBBLE FRUIT FLAVOR- sodium fluoride gel, dentifrice

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Available from:
Colgate-Palmolive
Administration route:
DENTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Anticavity helps protect against cavities
Authorization status:
OTC monograph final
Authorization number:
35000-365-44

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COLGATE KIDS LLAMA MILD BUBBLE FRUIT FLAVOR- sodium fluoride gel, dentifrice

Colgate-Palmolive

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.

----------

Colgate

Kids Llama

Mild Bubble Fruit

Flavor

Drug Facts

Active ingredient

Sodium Fluoride

0.24% (0.15% w/v fluoride ion)

Purpos e

Anticavity

Us e

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.

Ques tions ?

1-800-468-6502

Dist. by:

COLGATE-PALMOLIVE COMPANY

®

®

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 124 g Tube Label

Colgate

Anticavity Fluoride Toothpaste

Maximum

Cavity Protection*

Mild BUBBLE FRUIT

LESS

MESS

Accepted

American

Dental

Association ®

NET WT

4.4 OZ (124g)

COLGATE KIDS LLAMA MILD BUBBLE FRUIT FLAVOR

sodium fluoride gel, dentifrice

Colgate -Palmolive

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:350 0 0 -36 5

Route of Administration

DENTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SO DIUM FLUO RIDE (UNII: 8 ZYQ1474W7) (FLUORIDE ION - UNII:Q8 0 VPU40 8 O)

FLUORIDE ION

1.1 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

SO RBITO L (UNII: 50 6 T6 0 A25R)

476 mg in 1 g

WATER (UNII: 0 59 QF0 KO0 R)

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

PO LYETHYLENE GLYCO L 6 0 0 (UNII: NL4J9 F21N9 )

CARBO XYMETHYLCELLULO SE SO DIUM, UNSPECIFIED FO RM (UNII: K6 79 OBS311)

SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141J)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

D&C YELLO W NO . 10 (UNII: 35SW5USQ3G)

Product Characteristics

Color

GREEN

S core

S hap e

S iz e

Flavor

FRUIT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:350 0 0 -36 5-44

124 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

12/21/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt355

12/21/20 20

Labeler -

Colgate-Palmolive (001344381)

Revised: 12/2020

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