MedPath

Isopropyl Alcohol

Sound Body 804.003/804AA 91% Isopropyl Alcohol

Approved
Approval ID

2c941c08-929c-43c9-966b-279086afca96

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

Big Lots

DUNS: 017885351

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Isopropyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50594-804
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 91 mL in 100 mL
Code: ND2M416302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/10/2025

principal display panel

SOUNDBODY™

First Aid Antiseptic

91% Isopropyl Alcohol

First Aid Antiseptic

WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

CAUTION: Do not point at self or others; product will squirt when squeezed.

Use only in a well-ventilated area; fumes can be harmful

32 FL OZ (1 QT) 946 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/10/2025

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/10/2025

ADVERSE REACTION

Manufactured for Big Lots By: Vi-Jon, LLC.

8515 Page Avenue St. Louis, MO 63114

V#425040 Item#804

Pat. D675, 101

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/10/2025

Caution

Fumes can be acutely irritating to skin, eyes and respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 6/10/2025

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/10/2025

When using this product

  • do not get into eyes
  • do not inhale
  • do not apply over large areas of the body
  • do not use longer than 1 week

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/10/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/10/2025

Keep out of reach of children

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/10/2025

Directions

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

WARNINGS SECTION

LOINC: 34071-1Updated: 6/10/2025

Warnings

**For external use only.**If taken internally serious gastric disturbances will result.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/10/2025

Active ingredient

Isopropyl alcohol 91%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/10/2025

Purpose

First aid antiseptic

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/10/2025

other information

  • does not contain, nor is intended as a substitute for grain or ethyl alcohol

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/10/2025

Inactive ingredient

water

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/10/2025

Questions?

1-888-593-0593

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Isopropyl Alcohol - FDA Drug Approval Details