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Ethyl Rubbing Alcohol

Basics_Solimo 876.002/876AC Ethyl Rubbing Alcohol

Approved
Approval ID

5369424a-ccbd-4dc6-af6b-7876484a9fe6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

Amazon.Com Services LLC

DUNS: 128990418

Products 1

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

Ethyl Alcohol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72288-876
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Ethyl Alcohol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (5)

ACETONEInactive
Code: 1364PS73AF
Classification: IACT
DENATONIUM BENZOATEInactive
Code: 4YK5Z54AT2
Classification: IACT
METHYL ISOBUTYL KETONEInactive
Code: U5T7B88CNP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLActive
Quantity: 70 mL in 100 mL
Code: 3K9958V90M
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/20/2025

principal display panel

Solimo

Ethyl Rubbing Alcohol

70% by volume

First aid antiseptic

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

Use only in a well-ventilated area; fumes may 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: 5/20/2025

Uses

first aid to help prevent the risk of infection in:

  • minor cuts
  • scrapes
  • burns

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 5/20/2025

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.

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 5/20/2025

ADVERSE REACTION

Dist. by: Amazon.com Services, LLC

Seattle, WA 98109 1-877-485-0385

2022 Amazon.com, Inc. or its afiliates.

All rights reserved. www.amazon.com/amazonbasics

DSP-TN-21091 DSP-MO-20087

Pat. D675,101

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/20/2025

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 bandage, let dry first

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/20/2025

Inactive ingredients

acetone, denatonium benzoate, methyl isobutyl ketone, water

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/20/2025

Active Ingredient

Ethyl alcohol 70%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/20/2025

Purpose

First aid antiseptic

WARNINGS SECTION

LOINC: 34071-1Updated: 5/20/2025

Warnings

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

Flammable.

  • Keep away from fire or flame, heat, spark, electrical

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/20/2025

Ask a doctor before use

for deep or puncture wounds, animal bites or serious burns

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/20/2025

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: 5/20/2025

Stop use and ask a doctor if

condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/20/2025

Keep out of reach of children.

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

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Ethyl Rubbing Alcohol - FDA Drug Approval Details