Oral-dent
FDA Label NDC 66969-6014

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by International Cosmetic Limited for the product Oral-dent (NDC 66969-6014). 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 active ingredients (w/v), purpose, keep out of reach of children., uses, warnings, 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

Active Ingredients (W/V)

Eucalyptol 0.092%
Thymol 0.064%
Methyl Salicylate 0.060%
Menthol 0.042%

Purpose

Antiplaque/Antigingivitis

Keep Out Of Reach Of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

Helps kill germs that cause plaque, gingivitis and bad breath.

Warnings

  • Do not swallow 
  • Not to be used by children under 12 years of age 

Directions

Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis.

Other Information

  • Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (590-860 F)
    • Do not use if security band around cap is missing or broken

Inactive Ingredients

Water, Alcohol (15%), Sorbitol Solution, Poloxamer 407, Benzoic Acid, Flavour, Sodium Saccharin, Sodium Citrate, Citric acid, D&C Yellow No.10, FD&C Green No. 3.

Other

Manufactured for

International Cosmetics Ltd.

ICL Drive, Bhagowtie Trace,

San Juan, Trinidad & Tobago, W.I.

INFO. CALL:1-868-675-2674 

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