Active Ingredient(S)
Alcohol 63.1% v/v. Purpose: Antiseptic
Waterless Alcohol Hand Sanitizer Gel
FDA Label NDC 75086-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiangsu Manwei Pharmaceutical Co.,ltd for the product Waterless Alcohol Hand Sanitizer Gel (NDC 75086-009). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient(s), purpose, method of use, matters needing attention, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer,killing microorganisms: can kill staphylococcus aureus Escherichia coli. Candida albicans.
Method Of Use
- surgical hand disinfection: after washing hands and forearms in accordance with the requirements of"medical personnel hand hygiene code", dry them with sterile towel,evenly apply the product to the hands 1-2 times,and the effect is 0.5 min
- hygienic hand disinfection: evenly apply this product to the hand 1-2 times, and the effect is. 5 min
Matters Needing Attention
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
Store in a cool and ventilated place,This product is inflammable, please keep away from the source of fire.
Inactive Ingredients
WATER,CARBOMER,TOCOPHERYL ACETATE
* Please review the disclaimer below.
