Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride Rinse
FDA Label NDC 0126-0034

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 Oral Pharmaceuticals, Inc. for the product Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride (NDC 0126-0034). 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, inactive ingredients, other information, 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 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

  • ✓ORTHODONTIST RECOMMENDED
  • ✓HELPS STRENGTHEN ENAMEL
  • ✓HELPS PREVENT CAVITIES

    • GUSHING GRAPE

    16.9 FL OZ (1.05 PT) 500 mL

    IMPORTANT: Read directions for proper use

    ADA
    Accepted
    American
    Dental
    Association ®

    P9910320

    Principal Display Panel (500 mL Bottle Label)

    Principal Display Panel (500 mL Bottle Label)

* Please review the disclaimer below.