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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ISOPROPYL ALCOHOL: 2,775 Adverse Event Reports & Safety Profile

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2,775
Total FAERS Reports
1,870 (67.4%)
Deaths Reported
1,947
Hospitalizations
2,775
As Primary/Secondary Suspect
2,030
Life-Threatening
2,172
Disabilities
Apr 26, 2019
FDA Approved
Your Military Exchanges
Manufacturer
OTC
Status

Route: TOPICAL · Manufacturer: Your Military Exchanges · FDA Application: 210872 · HUMAN OTC DRUG · FDA Label: Available

Patent Expires: May 23, 2028 · First Report: 2006 · Latest Report: 20250513

What Are the Most Common ISOPROPYL ALCOHOL Side Effects?

#1 Most Reported
Pemphigus
1,280 reports (46.1%)
#2 Most Reported
Joint swelling
1,275 reports (45.9%)
#3 Most Reported
Glossodynia
1,267 reports (45.7%)

All ISOPROPYL ALCOHOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Pemphigus 1,280 46.1% 825 915
Joint swelling 1,275 46.0% 869 939
Glossodynia 1,267 45.7% 928 989
Systemic lupus erythematosus 1,260 45.4% 915 1,004
Pericarditis 1,258 45.3% 788 899
Helicobacter infection 1,250 45.1% 847 972
Folliculitis 1,248 45.0% 912 962
Hand deformity 1,246 44.9% 914 976
Impaired healing 1,246 44.9% 898 936
Hypersensitivity 1,244 44.8% 838 934
Rash 1,242 44.8% 893 1,008
Infusion related reaction 1,237 44.6% 899 945
Irritable bowel syndrome 1,230 44.3% 836 920
Pain 1,230 44.3% 804 943
Hepatic enzyme increased 1,224 44.1% 836 956
Wound 1,218 43.9% 922 957
Swelling 1,203 43.4% 842 967
Fatigue 1,199 43.2% 853 917
Synovitis 1,198 43.2% 860 961
Confusional state 1,197 43.1% 861 926

Who Reports ISOPROPYL ALCOHOL Side Effects? Age & Gender Data

Gender: 98.0% female, 2.0% male. Average age: 45.2 years. Most reports from: CA. View detailed demographics →

Is ISOPROPYL ALCOHOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2006 1 1 0
2007 1 0 0
2008 2 2 2
2010 2 0 1
2011 3 1 2
2013 1 0 1
2014 7 0 1
2015 26 10 19
2016 5 0 1
2017 3 1 1
2018 3 1 1
2019 5 1 0
2020 12 0 1
2021 13 1 2
2022 3 0 0
2025 1 0 0

View full timeline →

What Is ISOPROPYL ALCOHOL Used For?

IndicationReports
Product used for unknown indication 2,363
Rheumatoid arthritis 190
Foetal exposure during pregnancy 59
Infection prophylaxis 9
Antibiotic prophylaxis 6
Ear congestion 6

ISOPROPYL ALCOHOL vs Alternatives: Which Is Safer?

ISOPROPYL ALCOHOL vs ISOPROPYL ALCOHOL\LEUPROLIDE ISOPROPYL ALCOHOL vs ISOPROPYL ALCOHOL\LEUPROLIDE\NORETHINDRONE ISOPROPYL ALCOHOL vs ISOPROTERENOL ISOPROPYL ALCOHOL vs ISOSORBIDE ISOPROPYL ALCOHOL vs ISOSORBIDE DINITRATE ISOPROPYL ALCOHOL vs ISOSORBIDE MONONITRATE ISOPROPYL ALCOHOL vs ISOTRETINOIN ISOPROPYL ALCOHOL vs ISRADIPINE ISOPROPYL ALCOHOL vs ISTRADEFYLLINE ISOPROPYL ALCOHOL vs ITACITINIB

Official FDA Label for ISOPROPYL ALCOHOL

Official prescribing information from the FDA-approved drug label.

Drug Description

Drug Facts Active Ingredient Isopropyl Alcohol 70% v/v Purpose Antiseptic Use For preparation of the skin prior to injection to reduce the risk of infection.

Warnings

For external use only. Flammable: Keep away from fire or flame. Do not use With electrocautery procedures. In or near the eyes. On mucous membranes. On irritated or damaged skin. Stop use and ask a doctor if Irritation or redness develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging

Information NDC Code: 84985-700-01 Package Description: 100 prep pads per carton Each pad contains 0.4 mL Product Information Product Type: Human OTC Drug Route of Administration: Topical

FDA Approved Uses (Indications)

Use for preparation of skin prior to injection,apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the inside to the outside, and gradually apply the product for two times, the disinfection area should be more than 5cmx5cm, and the action time should be1min.Please clean before disinfection.

Dosage & Administration

Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampule and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

Directions use in a well ventilated area do not allow solution to pool; tuck prep towels to absorb solution, and then remove remove applicator from package; do not touch sponge hold the applicator with the sponge down. Pinch wings only once to activate the ampules and release the antiseptic. wet the sponge by pressing and releasing the sponge against the treatment area until liquid is visible on the skin completely wet the treatment area with antiseptic dry surgical sites (e.g., abdomen or arm): use repeated back-and-forth strokes for 30 seconds moist surgical sites (e.g., inguinal fold): use repeated back-and-forth strokes for 2 minutes allow the solution to completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). Do not blot or wipe away. discard prepping materials, including solution soaked materials. It is not necessary to use the entire amount available.

Contraindications

CONTRAINDICATION Should not be used on full-term or premature babies less than 1 month

Known Adverse Reactions

ADVERSE REACTION DISTRIBUTED BY: Pharmacy Value Alliance LLC, 407 East Lancaster Avenue, Wayne, PA 19087 www.emersongroup.com If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Pat. D675, 101

Warnings

Warnings For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: solution contains alcohol and gives off flammable vapors avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable. do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow the solution to pool remove wet materials from prep area

Warnings For external use only. Flammable, keep away from fire or flame. T o reduce risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery solution contains alcohol and gives off flammable vapors . avoid getting solution into hairy areas. Hair may take up to 1 hour to dry. Wet hair is flammable . do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) do not allow the solution to pool remove wet materials from prep area

Precautions

Flammable Keep away from fire or flame, heat, spark, electrical Do not use as a fuel source

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.

Active Ingredient

BD PurPrep™ 10.5 mL Applicator Active Ingredients Isopropyl Alcohol 7.2% w/w Povidone-Iodine 8.3% w/w (0.83% available iodine)

BD PurPrep™ 26 mL Applicator Active Ingredients Isopropyl Alcohol 72.5% w/w Povidone-iodine 8.3% w/w (0.83% available iodine)

Inactive Ingredients

Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water

Inactive ingredients Acrylates Copolymer, Acrylates/Octylacrylamide Copolymer, Aminomethyl Propanol, Polyethylene Glycol, USP Purified Water