HAND SANITIZER- alcohol gel 
Tecnoglobal Ph7, S.a. 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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Ecopili 75470-800

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Personal care hand rub to help reduce bacteria that potentially can cause disease.

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.

Directions

Other information

Inactive ingredients

WATER, GLYCERIN, PROPYLENE GLYCOL, AMINOMETHYLPROPANOL, PHENOXYETHANOL / IODOPROPYNLBUTYLCARBAMATE, TETRASODIUM EDTA, EXT. VIOLET 2

Package Label - Principal Display Panel

3785 mL NDC: 75470-800-01

3785

960 mL NDC: 75470-800-02

960

500 mL NDC: 75470-800-01

LABEL 1

490 mL NDC: 75470-800-04

490mL

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75470-800
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75470-800-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75470-800-02960 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75470-800-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:75470-800-04490 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Tecnoglobal Ph7, S.a. De C.v. (813006665)
Establishment
NameAddressID/FEIBusiness Operations
Tecnoglobal Ph7, S.a. De C.v.813006665manufacture(75470-800)

Revised: 9/2020
Document Id: ae6a6337-1e26-341f-e053-2995a90af14b
Set id: aa1aa97a-1c5d-9230-e053-2a95a90ab710
Version: 3
Effective Time: 20200903
 
Tecnoglobal Ph7, S.a. De C.v.