COLGATE KIDS BATMAN ALCOHOL FREE ANTICAVITY MOUTHWASH BAT-SIGNAL BUBBLE FRUIT- sodium fluoride rinse

Colgate Kids Batman Alcohol Free Anticavity Mouthwash Bat-Signal Bubble Fruit by

Drug Labeling and Warnings

Colgate Kids Batman Alcohol Free Anticavity Mouthwash Bat-Signal Bubble Fruit by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

COLGATE KIDS BATMAN ALCOHOL FREE ANTICAVITY MOUTHWASH BAT-SIGNAL BUBBLE FRUIT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-332
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	BLUE	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-332-84	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2019
2	NDC: 35000-332-52	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	06/28/2019

Labeler - Colgate-Palmolive (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-332)