ISOPROPYL ALCOHOL: 2,775 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is ISOPROPYL ALCOHOL Used For?
| Indication | Reports |
|---|---|
| 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?
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