FDA Label for Colgate Enamel Health Mouthwash

View Indications, Usage & Precautions

Colgate Enamel Health Mouthwash Product Label

The following document was submitted to the FDA by the labeler of this product Colgate-palmolive Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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Drug Facts

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022


Active Ingredient



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


Purpose



Anticavity


Uses



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


Inactive Ingredients



water, glycerin, propylene glycol, sorbitol, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, phosphoric acid, sodium saccharin, cetylpyridinium chloride, disodium phosphate, potassium sorbate, sucralose, FD&C green no. 3


Other Information



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


Questions?



1-800-468-6502


Principal Display Panel - 1 L Bottle Label



NEW

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

ENAMEL
HEALTH

STRENGTHENS ENAMEL EVEN
WHERE BRUSHING MAY MISS

WITH FLUORIDE

* Please review the disclaimer below.