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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Noean 410-01 to 410-4

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.

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, carbomer, proplyene glycol, phenoxyethanol/iodopropynylbutylcarbamate, aminomethlypropanol, ext. violet 2, tetrasodium EDTA.

Package Label - Principal Display Panel

250 mL NDC: 75470-410-04

1 Gal

250 mL NDC: 75470-410-03

1000

250 mL NDC: 75470-410-02

500

250 mL NDC: 75470-410-01

V.1

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75470-410
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75470-410-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
2NDC:75470-410-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
3NDC:75470-410-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
4NDC:75470-410-043780 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(75470-410)

Revised: 8/2020
Document Id: adb5ba2e-94c5-05ea-e053-2a95a90a73db
Set id: a7c0d0aa-5c7f-1f0b-e053-2995a90a2041
Version: 2
Effective Time: 20200825
 
Tecnoglobal Ph7, S.a. De C.v.