HAND SANITIZER EARTHZEN- hand saniziter earthzen gel 
PROBEMEX S.A. DE CV

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HAND SANITIZER EARTHZEN

ACTIVE INGRIDIENT

ETHYL ALCOHOL 70%

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

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

WARNING

WARNING FLAMMABLE KEEP AWAY FROM HEAT

DOSAGE

PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACE

KEEP OUT OF REACH

KEEP OUT OF REACH OF CHILDREN

PACKAGE

EARTH42955-011-01

42955-011-02

42955-011-03

HAND SANITIZER EARTHZEN 
hand saniziter earthzen gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42955-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.22 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 27.9 mL  in 100 mL
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) 0.14 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.001 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 0.51 mL  in 100 mL
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) 0.33 mL  in 100 mL
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42955-011-0152 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
2NDC:42955-011-031.5 mL in 1 DOSE PACK; Type 0: Not a Combination Product08/12/2020
3NDC:42955-011-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product08/12/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/12/2020
Labeler - PROBEMEX S.A. DE CV (813566395)
Registrant - PROBEMEX S.A. DE CV (813566395)
Establishment
NameAddressID/FEIBusiness Operations
PROBEMEX S.A. DE CV813566395manufacture(42955-011)

Revised: 8/2020
Document Id: acb3e182-6032-06f1-e053-2995a90a161c
Set id: acb3e182-6031-06f1-e053-2995a90a161c
Version: 1
Effective Time: 20200812
 
PROBEMEX S.A. DE CV