HAND SANITIZER 70 PERCENT- ethyl alcohol gel 
Emilia Cosmetics Ltd

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

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTIMICROBIAL

USES

HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM OPEN FIRE OR FLAME.

WHEN USING THIS PRODUCT DO NOT USE NEAR THE EYES. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH AND LASTS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

WATER, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, ETHYLHEXYLGLYCERIN, PANTHENOL (PRO-VITAMIN B5), FRAGRANCE.

01b LBL_sani-X gel_front

01b LBL_sani-X gel_DF Box

HAND SANITIZER  70 PERCENT
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-104
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
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-104-022 mL in 1 POUCH; Type 0: Not a Combination Product05/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/06/2020
Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 5/2020
Document Id: 53b1052e-b0dd-45ba-a844-ae3e64329d32
Set id: 1596ba96-037b-401c-ab54-585b90334d92
Version: 3
Effective Time: 20200523
 
Emilia Cosmetics Ltd