Active Ingredient(S)
Ethyl Alcohol 75% v/v, Antiseptic
Sanitizing Antibacterial Wipes
FDA Label NDC 79621-628
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tianjin Zejun Int'l Trade Co., Ltd for the product Sanitizing Antibacterial Wipes (NDC 79621-628). 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, Hand Sanitizer
Use
For handwashing to decrease bacteria on the skin.
Warnings
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 develops and continues for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Supervise children under 6 years of age when using this product to avoid swallowing.
Directions
- Tear open packet, remove and unfold pre-moistened tissue.
- Wipe hands including nails and cuticles.
- Allow to dry without wiping.
- Discard properly after use.
Other Information
- Store at room temperature.
- Avoid freezing and excessive heat above 40˚C (104˚F)
Inactive Ingredients
Aqua(Water).
Package Label - Principal Display Panel
80 Wipes in 1 Pail NDC: 79621-628-01
Package Label (Label Revised)
* Please review the disclaimer below.
