Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Alcohol Wipes
FDA Label NDC 11749-050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pnr Group, Llc for the product Alcohol Wipes (NDC 11749-050). 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, Sanitizing wet wipes
Use
to help reduce bacteria on the skin that may cause disease.
Warnings
For external use only. Flammable. Keep away from fire and flame.
Do Not Use
Do not use in or near the eyes. In case of contact with eyes, flush thoroughly with water. Use wipes only on unbroken, intact skin. If you have sensitive skin or certain allergies, check the list of ingredients on the label before using wipes. Do not ingest.
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 skin irritation or redness develops.
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
Wipe hands thoroughly, let skin dry and discard.
Keep out of reach of children. Children under 6 years use only under adult supervision.
Not recommended for infants.
Other Information
Do not store above 105 ℉. May discolor some fabrics.
Inactive Ingredients
purified water USP
Package Label - Principal Display Panel
50 WIPES NDC: 11749-050-50
* Please review the disclaimer below.
