Active Ingredient
Alcohol 70% v/v
Wolke Hand Sanitizer
FDA Label NDC 78207-000
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hidro Soluciones Integrales, S.a. De C.v. for the product Wolke Hand Sanitizer (NDC 78207-000). 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, purpose, uses, warnings, when using this product, do not use, stop use and ask a doctor if, 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
Uses
To decrease bacteria on the skin when water, soap & towel are not available - Recommended for repeated use.
Warnings
- For external use only.
Flammable - Keep away from fire or flame.
When Using This Product
keep out of eyes. In case of contact with eyes, rinse thoroughly with water.
Do Not Use
on broken or irritated skin.
Stop Use And Ask A Doctor If
irritation or redness develop and last more than 72 hours.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply enough product to wet hands. Rub hands together until dry. Supervise children in use of this product.
Other Information
- Do not store above 105 °F (40 °C).
- May discolor certain wood surfaces.
Inactive Ingredients:
Purified water, carbomer, triethanolamine, glycerin.
Package Labeling: 250Ml
Bottle (Bottle)
Package Labeling: 500Ml
Bottle2 (Bottle2)
Package Labeling: 900Ml
Bottle3 (Bottle3)
* Please review the disclaimer below.
