Purpose
Antiseptic, BeSafe Sanitizing Wipes
Besafe Sanitizing Wipes
FDA Label NDC 77693-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Besafe Industries, Llc for the product Besafe Sanitizing Wipes (NDC 77693-101). 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 purpose, active ingredient(s), other, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient(S)
Ethyl Alcohol 75%. Purpose: Antimicrobial
Other
This is a sanitizing wipe manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The sanitizing wipe is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Use
Helps reduce 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 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
- Use one wipe per object to avoid cross contamination.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Dispose of wipes in trash after use. Do not flush.
- Tightly close lid between uses to retain moisture.
- Do not reuse or refill this empty container.
Inactive Ingredients
glycerin, hydrogen peroxide, RO pure water
Package Label - Principal Display Panel
BeSafe 100 wipes Refill NDC: 77693-101-05
BeSafe 100 wipes Canister NDC: 77693-101-04
BeSafe 100 wipes NDC: 77693-101-03
BeSafe 60 wipes NDC: 77693-101-02
BeSafe 20 wipes NDC: 77693-101-01
80 wipes b NDC: 77665-101-07
60 wipes b NDC: 77665-101-06
50 wipes b NDC: 77665-101-05
100 wipes NDC: 77665-101-04
1 wipe NDC: 77665-101-03
10 wipes NDC: 77665-101-02
50 wipes NDC: 77665-101-01
* Please review the disclaimer below.
