Colgate kids bubblegum swirl rinse

Spl unclassified section

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

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

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 supervision

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

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, disodium phosphate, potassium sorbate, cetylpyridinium chloride, sucralose, D&C red no. 33

Other information

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

Questions?

1-800-468-6502

Spl unclassified section

Dist. by:
COLGATE-PALMOLIVECOMPANY
New York, NY 10022

Ingredients and appearance - Product information

Colgate kids bubblegum swirl rinse- Sodium fluoride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 35000-725
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 0.1 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Glycerin ( UNII: PDC6A3C0OX)
Propylene glycol ( UNII: 6DC9Q167V3)
Sorbitol ( UNII: 506T60A25R)
Potassium sorbate ( UNII: 1VPU26JZZ4)
Cetylpyridinium chloride ( UNII: D9OM4SK49P)
Saccharin sodium ( UNII: SB8ZUX40TY)
Levomenthol ( UNII: BZ1R15MTK7)
Sucralose ( UNII: 96K6UQ3ZD4)
Poloxamer 407 ( UNII: TUF2IVW3M2)
Poloxamer 338 ( UNII: F75JV2T505)
Sodium phosphate, dibasic, anhydrous ( UNII: 22ADO53M6F)
Polyoxyl 40 hydrogenated castor oil ( UNII: 7YC686GQ8F)
Phosphoric acid ( UNII: E4GA8884NN)
D&c red no. 33 ( UNII: 9DBA0SBB0L)

Product Characteristics

Color PINK Flavor MINT

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part355 USA

Labeler - Colgate-Palmolive Company( 068693167)

Principal display panel - 250 ml bottle label

NEW

ALCOHOL FREE

Colgate ®

Kids

Anticavity
Fluoride Rinse

Bubble Gum
Swirl

P9896332

8.4 FL OZ
(250 mL)

Protects
from
Cavities

Strengthens
Enamel

Cleans
the Whole
Mouth*

IMPORTANT: Read directions for proper use