MedPath

50% Rubbing

Swan 864.003/864AA-AC 50% Isopropyl Alcohol

Approved
Approval ID

68d3fabc-4640-4214-aead-8a918106af46

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Vi-Jon, LLC

DUNS: 088520668

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 Code0869-0864
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Isopropyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 50 mL in 100 mL
Code: ND2M416302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/12/2025

principal display panel

NDC 0869-0864-43

swan ®

50% Isopropyl Alcohol

  • First Aid Antiseptic
  • For Rubbing & Massaging

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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

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

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

16 FL OZ (1 PT) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/12/2025

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scarapes
  • burns

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/12/2025

Adverse reactions

Distributed by: Vi-Jon, LLC

8515 Page Ave.

St. Louis, MO 63114

Pat. D675, 101

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/12/2025

Active ingredient

Isopropyl alcohol 50%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2025

Warnings

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 5/12/2025

Caution

Fumes can be acutely irritating to skin, eyes and the 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: 5/12/2025

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/12/2025

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 unless directed by a doctor

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/12/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/12/2025

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: 5/12/2025

Directions

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 5/12/2025

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/12/2025

Inactive ingredient

water

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50% Rubbing - FDA Drug Approval Details