Quality Choice Amber
FDA Label NDC 63868-556

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Quality Choice Amber (NDC 63868-556). 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, purpose, uses, warnings, 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

Active Ingredients

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

Purpose

Antiplaque/Antigingivitis

Uses

To help reduce and prevent plaque and gingivitis

Warnings

Do not use for children under 12 years of age.

Keep Out Of Reach Of Children

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

  • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night.
  • Do not swallow.

Other Information

  • Store at room temperature.
  • Cold weather may cloud this product. Its antiseptic properties are not affected.

Inactive Ingredients

Water (Aqua), Alcohol (26.9%), Benzoic Acid, Poloxamer 407, Sodium Benzoate, Caramel.

Questions Or Comments?

1-248-449-9300

Label Copy

Image Of The Label (20803l)

Image Of The Label (20803l)

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