Derma Stat
FDA Label NDC 10802-8082

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rosedale Therapeutics, Llc for the product Derma Stat (NDC 10802-8082). 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:, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredients:, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

65% Ethyl Alcohol by volume

Otc - Purpose

Antiseptic

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Use: For hand washing to decrease bacteria on the skin.

Warnings

Warning: For external use only. Avoid contact with eyes. Contents under pressure. Do not puncture incinerate, use near fire, spark, flame, expose to heat or store above 120°F.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

Dosage & Administration

Directions: Dispense approximately four grams (palm full) into palm of one hand. Spread thoroughly over both hands and gently rub into skin until dry. Repeat application as often as required. Washing hands with soap and water is recommended after approximately 15 applications.

Inactive Ingredients:

Emulsifying wax, Isobutane, Propane, Purified water, Tert-butyl alcohol

Other

DERMA STAT® Antimicrobial Waterless Hand Foam meets the recommended guidelines for use as a Health Care Personnel Hand Wash. Use to help meet OSHA standards. Recommended for repeated use.

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