Short Term Oral Swab System
FDA Label NDC 53462-201

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 Swab System (NDC 53462-201). 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

→ Use

→ Warnings

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Questions

→ Other

→ Short Term Oral Swab System With Perox-a-mint Solution

Drug Facts


Active Ingredient	Purpose
PEROX-A-MINT SOLUTION:
1.5% Hydrogen peroxide	Oral debriding agent

Use

Aids in the removal of debris and secretions.

Warnings

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

Dip an Oral Swab into the Perox-A-Mint solution.
Clean teeth and oral cavity for approximately 1 minute.
Instruct to expectorate.
Apply Mouth Moisturizer as needed.
Discard after use.
Swabs are intended for single oral use only.
Use up to 4 times daily or as directed by a dentist or doctor.
Children under 12 years of age: supervise use.
Children under 3 years of age: consult a dentist or doctor.
Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
Ensure foam is intact after use. If not, remove any particles from oral cavity.