Active Ingredient
Alcohol 70%
Hand Sanitizer
FDA Label NDC 50058-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Roqueplast, S.a. De C.v. for the product Hand Sanitizer (NDC 50058-100). 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, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
■ For hand washing to decrease bacteria on the skin and ■ Recommended for daily and repeated use.
Warnings
For external use only. Flammable. Keep away from fire & flame
When Using This Product
■ do not use in the eyes. In case of contact, rinse eyes thoroughly with water
Stop Use And Ask A Doctor If
■ irritation and redness develop and persist for more than 72 hours
Keep Out Of Reach Of Children
If swallowed, get medical help or Poison Control Center right away.
Directions
■ Wet hands throughhly with product, briskly rub hands together until they are dry. ■ Supervise children in the use of this product.
Other Information
■ Store below 105°F
■ May discolor some fabrics
■ Store at 20°-25° C (68° to 72° F) ■ may discolor certain fabrics
Inactive Ingredients
distilled water, carbopol, triethanolamine, glycerin
Package Label
Package Label (Cmmndhndsntzrlbl)
* Please review the disclaimer below.
