XEPI RUB ET HAND SANITIZING HANDRUB- ethyl alcohol solution

XEPI Rub ET HAND SANITIZING HANDRUB by

Drug Labeling and Warnings

XEPI Rub ET HAND SANITIZING HANDRUB by is a Otc medication manufactured, distributed, or labeled by Sanmed Healthcare Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredients

Ethyl Alcohol 80.0% 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:

Hydrogen Peroxide 0.125% v/v, Water (aqua), Glycerin, Carbomer 940, Aminomethyl Propanol, Dettol Frag.

Questions or comments?

* Call: +91 40 4221 2432 / 33

* Email: info@sanmed.in

SPL UNCLASSIFIED SECTION

World Health Organization Recommended Formulation

Manufactured by:

Sanmed Healthcare Pvt. Ltd.

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

Karakapatla - 502279. India.

Packaging

INGREDIENTS AND APPEARANCE

XEPI RUB ET HAND SANITIZING HANDRUB 
ethyl alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81357-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER 940 (UNII: 4Q93RCW27E)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81357-101-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020
2	NDC: 81357-101-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020
3	NDC: 81357-101-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020
4	NDC: 81357-101-04	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020
5	NDC: 81357-101-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020
6	NDC: 81357-101-06	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/28/2020

Labeler - Sanmed Healthcare Private Limited (854248431)

Establishment
Name	Address	ID/FEI	Business Operations
Sanmed Healthcare Private Limited		854248431	manufacture(81357-101)