Alcohol
FDA Label NDC 61767-305

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Alcohol (NDC 61767-305). 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 otc - active ingredient, purpose, warnings, indications & usage, keep out of reach of children, dosage & administration, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient                                       Purpose

Isopropyl Alcohol 99% v/v                         Antiseptic

Purpose

First aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

Warnings

  • For external use only
  • Flammable, keep away from fire or flame, heat, spark, electrical.
  • Not for use with electrocautinary devices or procedures
  • Ask a doctor before use if you have deep puncture wounds, animal bites or serious burns.
  • Stop use and ask a doctor if condition persist or gets worse.

    • For rubbing and massaging:

    • Caution: Do not apply to irritated skinor if excessive irritation develops
    • Avoid getting into eyes or mucous membranes

Indications & Usage

When using this product:

  • do not get in eyes
  • do not apply over large areas of the body
  • do not use longer than 1 week unless directed by a doctor

Keep Out Of Reach Of Children

Keep out of reach of children.

IIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

DIRECTIONS:

  • clean the affected area
  • apply a small amount of this product on the affected area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged let dry first

Other Information

  • Store at room temperature: 15 deg C to 30 deg C   59 deg F to 86 deg F
  • avoid excessive heat
  • Does not contain, nor is it intended as a substitute for grain or ethyl alcohol
  • Will produce serious gastric disturbances if taken internally

Inactive Ingredient

Inactive Ingredient

  • Water

Principal Display Panel

DYNAREX 99% ISOPROPYL ALCOHOL

99 IPA BP.jpg

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