Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Alcohol Wipes
FDA Label NDC 78450-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avatech Corp. for the product Alcohol Wipes (NDC 78450-001). 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 active ingredient(s), inactive ingredients, purpose, otc - when using, do not use, otc - stop use, otc - keep out of reach of children, use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredients
Water
Purpose
SUITABLE FOR : Use on a varlety of hard, nonporous surfaces where bacteria or unpleasant odors are a concern, including but not limited to: countertops, food preparation surfaces, floors, appliances, garbage cans, changing tables, appliances, garbage cans,changing tables, highchairs,cribs,children's toys, toilet seats,door knobs,desks,pet habitats.
Otc - When Using
This product is used to wipe hands, faces, skins, etc. It can also be used to clean many kinds of places.
Do Not Use
on children less than 2 months of age
on open skin wounds
Otc - Stop Use
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.
Use
DIRECTIONS FOR USE:
It is a violation of Federal law to use this product in a manner inconsistent with its labeling. For heavily soiled or greasy areas, pre-cleaning is required.
TO OPEN PACKAGE:
Open the lid and pull corner of wipe from top of the stack. Drag the wipe out of the opening, pulling it through to next perforation and tear off the wipe if necessary. Close lid immediately to retain moistrue.
TO CLEAN:
Wet the surface with the wipe & wipe clean. For stubbom stains, let stand for a few minutes.
TO DISINFECT & DEODORIZE:
1. Wet the surface with the wipe (spot test to check surface compatibility).
2 . Leave visibly wet for 10 minutes. Allow to air-dry. No rinsing or wiping is required (even on food contact surfaces).
WIPE MATERIAL:
Spunlace non-woven fabric Gluten free. No phosphates. Learn more at www.schneidercare.com
Directions
Use it as needed, after following the usage instructions.
For external use only.
Warnings
Do not apply this product to red and swollen skin, wound or any part sensitive to it.
Keep this product out of children’s reach in case they might eat it.
Alcohol is violatile, please use it as soon as possible after opening, store it in a cool and dry place, avoid direct sunlight and open fire, and avoid contact with eyes and damaged skin.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
- Dispose of wipe in trash after use. Do not flush. Tightly close lid between uses to retain moisture. Non refillable container. Do not reuse or refill this empty bag. Offer empty bag for recycling. If recycling is not available, discard in trash.
Package Label - Principal Display Panel
50 CLOTH IN 1 BAG NDC:78450-001-01
1 CLOTH IN 1 BAG NDC:78450-001-02
10 CLOTH IN 1 BAG NDC:78450-001-03
80 CLOTH IN 1 BAG NDC:78450-001-04
* Please review the disclaimer below.
