COLGATE KIDS BATMAN ALCOHOL FREE ANTICAVITY MOUTHWASH BAT-SIGNAL BUBBLE FRUIT- sodium fluoride rinse 
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 Batman Alcohol Free Anticavity Mouthwash Bat-Signal Bubble Fruit®

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

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

Other information

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

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, blue 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

ALCOHOL FREE

Colgate®

Kids Anticavity Fluoride Rinse

8.4 FL OZ
(250 mL)

Strengthens
Enamel
Protects from
Cavities
Cleans the
Whole Mouth*

Bat-Signal BUBBLE FRUIT®

IMPORTANT: Read directions for proper use

P9927662

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label
COLGATE KIDS BATMAN ALCOHOL FREE ANTICAVITY MOUTHWASH BAT-SIGNAL BUBBLE FRUIT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-332
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
POLOXAMER 338 (UNII: F75JV2T505)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-332-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/201912/31/2023
2NDC:35000-332-52500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/28/201912/31/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/28/201912/31/2023
Labeler - Colgate-Palmolive (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-332)

Revised: 12/2019
 
Colgate-Palmolive