EJK HAND SANITIZER- alcohol gel 
E.J.K. QUIMICOS SA. DE C.V.

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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EJK Hand Sanitizer, Alcohol 70%

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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.

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.

Directions

Other information

Inactive ingredients

Water, Glycerin, Hydroxyethyl cellulose, Triethanolamine, Benzalkonium Chloride, Hydrogen Peroxide.

Package Label - Principal Display Panel

1000 mL NDC: 79157-001-01

PDP 1000mL

EJK HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79157-002
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
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.075 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK) 0.3 mL  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 28.025 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.5 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79157-002-011000000 mL in 1 CONTAINER; Type 0: Not a Combination Product07/06/2020
2NDC:79157-002-02200000 mL in 1 DRUM; Type 0: Not a Combination Product07/06/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/06/2020
Labeler - E.J.K. QUIMICOS SA. DE C.V. (812896292)
Registrant - E.J.K. QUIMICOS SA. DE C.V. (812896292)
Establishment
NameAddressID/FEIBusiness Operations
E.J.K. QUIMICOS SA. DE C.V.812896292manufacture(79157-002)

Revised: 7/2020
Document Id: a9cc8035-10d7-25e5-e053-2a95a90ab2ab
Set id: a9ca8aaa-ea77-7eb5-e053-2995a90adef9
Version: 2
Effective Time: 20200706
 
E.J.K. QUIMICOS SA. DE C.V.