The following Structured Product Label (SPL) was submitted to the FDA by Grafenberg Lab for the product Safetwipes (NDC 77987-001). 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 other, active ingredient, purpose, use, warning, do not use, stop use, keep out, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
The hand sanitizing wipes are manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product:
Alcohol (75%, 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.
Alcohol 75% v/v. Purpose: Antiseptic
Antiseptic hand wipes
Hand wipes to help reduce bacteria from skin.
For external use only. Flammable. Keep away from heat or flame
Do not use in or contact the eyes.
Stop use and ask a doctor if irritation or rash occurs.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Open label slowly and pull out wipe. Unfold wipe and thoroughly wipe hands. Discard wipe after single use. Make sure to reseal label completely to retain moisture.
Store at room temperature.
Lot No. Manufacturing date and Expiration date can be found on package.
Water.
* Please review the disclaimer below.
