Active Ingredient(S)
BENZALKONIUM CHLORIDE 0.15% v/v. Purpose: Antiseptic
Antibacterial Hand Wipes
FDA Label NDC 81614-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Orange (fujian) Sanitary Products Co., Ltd. for the product Antibacterial Hand Wipes (NDC 81614-015). 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, use, warnings, 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, Antibacterial Hand Wipes
Use
USES:Single use wipes to cleanse hands and help prevent the spread of bacteria.
Warnings
- For external use only.
- Do not replace wipes used for medical procedures.
- These wipes are meant for general cleansing.
- Flammable. Keep away fire or sources of heat.
- Avoid contact with eyes.
- If eyes contact occurs, flush eyes with water.
- Store at room temperature 59 ℉（15℃）-86 ℉（30℃）.
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
If irritation and redness develop. If condition continues, consult your health care practitoner.
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 between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
WATER,ALOE EXTRACT,SODIUM PHENYLKALATE
Package Label - Principal Display Panel
20 cloth NDC: 81614-015-20
50 cloth NDC: 81614-015-50
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