Instant Hand Sanitizer .7 g/mL
alcohol · GEL · Safetec of America, Inc.
Instant Hand Sanitizer is a gel containing alcohol at .7 g/mL, taken topical. Manufactured by Safetec of America, Inc..
Key Facts
- Brand Name
- Instant Hand Sanitizer
- Generic Name
- alcohol
- NDC Code (Product)
61010-4111- Manufacturer
- Safetec of America, Inc.
- Strength
- .7 g/mL
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- 505G(a)(3)
- Marketing Start
- 12/16/2010
Recall History
Albek De Mexico S.A. De C.V.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
AMS Packaging Inc
Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Hillyard GMP
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
4e Brands North America, Llc
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
WORLD EVENT PROMOTIONS, LLC
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
4e Brands North America, Llc
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
Liq-E S.A. De C.V.
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Albek De Mexico S.A. De C.V.
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Omega & Delta Co., Inc.
Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
Liq-E S.A. De C.V.
Chemical Contamination: Products contain methanol and were below the label claim for ethanol content
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses for handwashing to decrease bacteria on skin recommended for repeated use
Dosage & Administration
Directions wet hands thoroughly with product allow to dry without wiping children under 6 should be supervised while using this product
Warnings
Warnings For external use only Flammable, keep away from fire or flame Do not use in the eyes. If this happens, rinse thoroughly with water Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours Keep out of reach of children If ingested get medical help or contact a Poison Control Center right away
Frequently Asked Questions
What is Instant Hand Sanitizer used for?
Instant Hand Sanitizer contains alcohol. It is a gel taken topical. Consult your doctor for specific uses.
Is Instant Hand Sanitizer a controlled substance?
Instant Hand Sanitizer is not classified as a controlled substance by the DEA.
What is the generic name for Instant Hand Sanitizer?
The generic name for Instant Hand Sanitizer is alcohol. There are 12 other brand versions of alcohol.
What is the NDC code for Instant Hand Sanitizer .7 g/mL?
The NDC (National Drug Code) for Instant Hand Sanitizer .7 g/mL is 61010-4111, listed by Safetec of America, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)