Colgate Enamel Strength Mouthwash Rinse
FDA Label NDC 35000-734

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colgate-palmolive - Do Not Use for the product Colgate Enamel Strength Mouthwash (NDC 35000-734). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Active Ingredient

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

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

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 407, Poloxamer 338, Flavor, PEG-40 Hydrogenated Castor Oil, Phosphoric Acid, Sodium Saccharin, Cetylpyridinium Chloride, Disodium Phosphate, Potassium Sorbate, Sucralose, Green 3

Questions?

1-800-468-6502

Principal Display Panel - 500 Ml Bottle Label

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

ENAMEL
STRENGTH®

ANTICAVITY PROTECTION
WITH FLUORIDE FOR STRONGER TEETH

Strengthens Enamel

Helps Prevent Cavities

Helps replenish natural calcium
back into enamel

10X LONGER LASTING COOL**

SPARKLING FRESH MINT

P9932531

16.9 FL OZ (1.05 PT) 500 mL

IMPORTANT:
Read directions
for proper use

Principal Display Panel (500 mL Bottle Label)

Principal Display Panel (500 mL Bottle Label)

* Please review the disclaimer below.