XEPI GEL 70E HAND SANITIZING HANDRUB- ethyl alcohol gel 
Sanmed Healthcare Private Limited

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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SANMED ACTIVE HYGIENE
XEPITM Gel 70E HAND SANITIZING Gel HANDRUB

DRUG FACTS

Active ingredients

Ethyl Alcohol 72.34% v/v

Purpose

Antiseptic Handrub

Uses:

* A hand rub to decrease microbial load on the skin

Warnings:

* For external use only

* Flammable. Keep away from fire or flame, heat sparks and sources of static discharge.

When using this product:

* Keep out of Eyes, Ears and Mouth.

* In case of contact with eyes, rinse promptly & thoroughly with water.

* Discontinue use if irritation and redness develop.

Stop use and ask a doctor if skin irritation or redness occurs for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

* Apply product onto hands, spread thoroughly & rub until dry.

Other information:

* Store below 30°C

* See Safety Data Sheet (SDS)

* For emergency medical information in USA, call ..........................

Inactive ingredients:

Water (aqua), Glycerin, Carbomer 940, Aminomethyl Propanol, Dettol frag.

Questions or comments ?

* Call: +91 40 42212432 / 33

* Email: info@sanmed.in

Manufactured by:

Sanmed Healthcare Pvt. Ltd.

Plot No: 56, TSIIC, Biotech Park Phase-III

Karakapatla - 502279. India.

Packaging

Xepigel

XEPI GEL 70E HAND SANITIZING HANDRUB 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81357-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72.34 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81357-102-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
2NDC:81357-102-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
3NDC:81357-102-03240 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
4NDC:81357-102-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
5NDC:81357-102-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
6NDC:81357-102-063785 mL in 1 BOTTLE; Type 0: Not a Combination Product12/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/28/2020
Labeler - Sanmed Healthcare Private Limited (854248431)
Establishment
NameAddressID/FEIBusiness Operations
Sanmed Healthcare Private Limited854248431manufacture(81357-102)

Revised: 12/2020
Document Id: 28db1962-d4fc-4add-858d-982aa60159db
Set id: dbdad00c-76b1-4835-8ddb-3a555e24b944
Version: 1
Effective Time: 20201229
 
Sanmed Healthcare Private Limited