FDA Label for Sanitizer Wipes
View Indications, Usage & Precautions
Sanitizer Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Organic Filling Solutions, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
This is an alcohol wipe manufactured in the USA
- 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 (3.2% 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.
Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Multi-purpose
Use
Single use wipes for hands. Close properly after dispensing to maintain purity, as alcohol by nature evaporates quickly. Dispose properly. Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.
Warnings
For external use only, hands, general cleaning. Does not replace wipes for medical procedures. Flammable; keep away from fire or flame. Do not ingest.
Do Not Use
- Stop use and ask a doctor if irritation and redness develop, condition persists for more than 72 hours
- Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
Otc - When Using
When using this product, keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.
Otc - Stop Use
Stop use and ask a doctor if irritation or redness develop. Condition persists for more than 72 hours
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
- Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.
Other Information
- Keep out of light, store at room temperature 59 - 86 degrees Farenheit
Inactive Ingredients
glycerin, purified water USP
Recent Major Changes
Single wipe use. Apply thoroughly to hands to cover all surfaces. Rub hands together until dry.
Package Label - Principal Display Panel
230 mL NDC: 76830-501-07
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