Alcohol Prep Pads 75 g/100g
Alcohol Prep Pads · SWAB · Qingdao Hainuo Biological Engineering Co., Ltd.
Alcohol Prep Pads is a swab containing alcohol prep pads at 75 g/100g, taken extracorporeal. Manufactured by Qingdao Hainuo Biological Engineering Co., Ltd..
Key Facts
- Brand Name
- Alcohol Prep Pads
- Generic Name
- Alcohol Prep Pads
- NDC Code (Product)
78149-201- Manufacturer
- Qingdao Hainuo Biological Engineering Co., Ltd.
- Strength
- 75 g/100g
- Dosage Form
- SWAB
- Route
- EXTRACORPOREAL, TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 05/20/2020
Recall History
Bound Tree Medical, LLC
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Bound Tree Medical, LLC
Labeling Incorrect Instructions: This recall has been initiated because the Instructions for Use included in the Epi-Safe Kits for the Epi-Safe Syringe (and/or the Safety Lok Syringe in Model 8600-01120) recommend a midpoint dosage of epinephrine for children between 0 lbs. and 66 lbs. of 0.15mL that has not been approved by FDA for children. Reliance on the current IFU and/or use of the Epi-Safe Syringe as instructed may result in the administration of an inappropriate dosage of epinephrine to young children experiencing anaphylaxis, especially those under 33 lbs. Additionally the Epi Safe syringe does not have the correct markings to allow a health care provider to draw up the correct dosage for children under 33 kg.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
Medline Industries, LP
Subpotent Drug
Wuxi Medical lnstrument Factory Co., Ltd.
Lack of assurance of sterility and cGMP deviations observed at the manufacturing site.
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug
MEDLINE INDUSTRIES, LP - Northfield
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Simple Diagnostics, Inc.
Lack of Assurance of Sterility and cGMP Deviations
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses First aid to help prevent infection in minor cuts, scrapes and burns For preparation of the skin prior to an injection
Dosage & Administration
Directions When used for first aid: 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. When used to prepare an injection site: Apply product to the injection site prior to injection.
Warnings
Warnings For External Use Only Flammable. Keep away from fire or flame Do not use in the eyes or over large areas of the body longer than 1 week unless directed by a doctor with electrocautery procedures Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns Stop use and ask a doctor if condition persists for more than 72 hours or gets worse Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Alcohol Prep Pads used for?
Alcohol Prep Pads contains Alcohol Prep Pads. It is a swab taken extracorporeal. Consult your doctor for specific uses.
Is Alcohol Prep Pads a controlled substance?
Alcohol Prep Pads is not classified as a controlled substance by the DEA.
What is the generic name for Alcohol Prep Pads?
The generic name for Alcohol Prep Pads is Alcohol Prep Pads. There are 2 other brand versions of Alcohol Prep Pads.
What is the NDC code for Alcohol Prep Pads 75 g/100g?
The NDC (National Drug Code) for Alcohol Prep Pads 75 g/100g is 78149-201, listed by Qingdao Hainuo Biological Engineering Co., Ltd..