Active Ingridient
ETHYL ALCOHOL 70%
Hand Sanitizer Earthzen
FDA Label NDC 42955-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Probemex S.a. De Cv for the product Hand Sanitizer Earthzen (NDC 42955-011). 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 ingridient, purpose, stop use, warning, directions, inactive, dosage, keep out of reach, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTISEPTIC
Stop Use
STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS AND LAST. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
Warning
WARNINGS: FLAMMABLE KEEP AWAY FROM HEAT OR FLAME. FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE YES. IN CASE OF CONTACT RINSE EYE THRROUGHLY WITH WATER
DO NOT USE ON CHILDREN LESS THAN 2 MONTHS OF AGE. OPEN SKIN WOUNDS AVOID CONTACT WIITH BROKER SKIN
WARNING FLAMMABLE KEEP AWAY FROM HEAT
Directions
PLACE ENOUGH PRODUCTO NO HANDS TO COVER ALL SUFACES. RUB HANDS TOGETHER UNTIL DRY.
SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING
OTHER INFORMATION: STORE BETWEEN 15-30C. AVOID FREEZING AND EXCESSIVE HEAT ABOCE 40C
MAY DISCOLOR CERTAIN FABRIC OR SUFACES
Inactive
WATER, CARBOMER PROPANEDIOL AMINOMETHYL PROPANOL PEG 40 HYDROGENATED CASTOR OIL GLYCERIN
Dosage
PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACE
Keep Out Of Reach
KEEP OUT OF REACH OF CHILDREN
Package
42955-011-01
42955-011-02
42955-011-03
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