Short Term Oral Care System
FDA Label NDC 53462-024

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sage Products Llc for the product Short Term Oral Care System (NDC 53462-024). 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 drug facts, use, warnings, otc - keep out of reach of children, directions, inactive ingredients, questions, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients For 6065 (Actives6002d 6065)

Active Ingredients For 6065 (Actives6002d 6065)

Use

Aids in the removal of secretions associated with sore mouth

Warnings

Do not use:

  • For more than 7 days unless told to do so by a doctor.
  • Avoid Swallowing.

    • Stop use and ask a doctor if:

    • Sore mouth symptoms do not improve in 7 days.
    • Swelling, rash or fever develops.
    • Irritation, pain or redness persists or worsens.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approx. one minute with 1/2 Tbsp. Instruct to expectorate.
  • Children under 12 yeras of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

Inactive Ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI42090), Yellow 6 (CI15985)

Questions

Call toll free 800-323-2220

Other

MADE IN U.S.A.

NOT MADE WITH NATURAL RUBBER LATEX

Short Term Oral Care System With Perox-A-Mint Solution

Short Term Kit 6002d (Shortcare 6002d R4745 Bag)

Short Term Kit 6002d (Shortcare 6002d R4745 Bag)

Peroxamint 6065 (Shortcare 6002d R3674i Bottle)

Peroxamint 6065 (Shortcare 6002d R3674i Bottle)

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