Aurora Alcohol Free Clean Mint
FDA Label NDC 63148-553

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apollo Health And Beauty Care for the product Aurora Alcohol Free Clean Mint (NDC 63148-553). 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 ingredient, 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 Ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antiplaque/Antigingivitis

Uses

  • Helps reduce and prevent plaque and gingivitis.
  • Helps control bacteria plaque that contributes to the development of gingivitis and bleeding gums.

Warnings

Ask a dentist if symptoms persist or condition worsens after regular use.

Keep Out Of Reach Of Children.

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

Directions

  • Use after your normal brushing and flossing routein; rinse toothpaste from mouth prior to use.
  • ​Adults and children 6 years of age and older:​ Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day.
  • do not swallow.
  • children 6 years to under 12 years of age: supervise use.
  • ​children under 6 years of age: do not use.

Other Information

Store at room temperature.

Inactive Ingredients

Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

Questions Or Comments?

1-866-695-3030

Label Copy

Image Of The Label (21365l)

Image Of The Label (21365l)

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