SANITIZING WIPES 70 PERCENT- ethyl alcohol solution 
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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SANITIZING WIPES

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

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

DISCARD USED WIPES IMMEDIATELY TO PREVENT CROSS CONTAMINATION.

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

AQUA, GLYCERIN, PANTHENOL, FRAGRANCE.

QUESTIONS?

CALL TOLL-FREE 1-866-942-9598 OR VISIT WWW.SANI-X.COM

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SANITIZING WIPES  70 PERCENT
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-101
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)  
PANTHENOL (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-101-013 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: 11/2020
Document Id: 7c4b2771-899c-4541-8d3f-f289eafd1b07
Set id: e7eae7b8-b058-455e-a6c0-9b83621f683c
Version: 5
Effective Time: 20201129
 
Emilia Cosmetics Ltd