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FDA Approval

Isopropyl Alcohol

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Big Lots
DUNS: 017885351
Effective Date
June 10, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Isopropyl alcohol(91 mL in 100 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Consumer Product Partners, LLC

119091520

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Consumer Product Partners, LLC

Big Lots

Consumer Product Partners, LLC

119091514

Products1

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

Isopropyl Alcohol

Product Details

NDC Product Code
50594-804
Application Number
M003
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
TOPICAL
Effective Date
June 10, 2025
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: ND2M416302Class: ACTIBQuantity: 91 mL in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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INDICATIONS & USAGE SECTION

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

DOSAGE & ADMINISTRATION SECTION

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

Warnings

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


ADVERSE REACTIONS SECTION

ADVERSE REACTION

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

8515 Page Avenue St. Louis, MO 63114

V#425040 Item#804

Pat. D675, 101


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Isopropyl alcohol 91%

OTC - PURPOSE SECTION

Purpose

First aid antiseptic

OTC - ASK DOCTOR SECTION

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

condition persists or gets worse

OTC - WHEN USING SECTION

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 - QUESTIONS SECTION

Questions?

1-888-593-0593


SPL UNCLASSIFIED SECTION

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.

OTHER SAFETY INFORMATION

other information

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

INACTIVE INGREDIENT SECTION

Inactive ingredient

water


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