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  5. Label Information: Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

FDA Label for Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. OTHER INFORMATION
    9. QUESTIONS?
    10. PRINCIPAL DISPLAY PANEL - 500 ML BOTTLE LABEL

Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride Product Label

The following document was submitted to the FDA by the labeler of this product Colgate Oral Pharmaceuticals, Inc.. 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.

Other



Drug Facts

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


Active Ingredient



Sodium fluoride 0.04% (0.02% 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 once a day after brushing your teeth with a toothpaste
  • vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute 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
  • ask a dentist or physician

Inactive Ingredients



water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40


Other Information



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


Questions?



1-800-468-6502


Principal Display Panel - 500 Ml Bottle Label



ALCOHOL FREE*

Colgate®

Phos•Flur®

Ortho Defense®

Anticavity Fluoride Rinse
Sodium Fluoride Acidulated Phosphate Solution

IDEAL PROTECTION
WHILE WEARING BRACES

* Please review the disclaimer below.