ANTIBACTERIAL ALCOHOL WIPES- alcohol cloth 
Urigel

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.

----------

Antibacterial Alcohol wipes 80U

Active Ingredient(s)

EthylAlcohol 80%. Purpose: Antibacterial

Purpose

Antibacterial, Hand Sanitizer

Use

For handwashing to decrease bacteria on skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product avoid contact with eyes. If contact occurs, 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.

Principal Display Panel 450 units

Main Label

80 each Sanitizer Wipes

Urigel Wipes 80 each80 Each NDC: 80924-110-01

100 Each Sanitizer Wipes

Urigel Wipes 100 each100 Each NDC:80924-110-02

450 Sanitizer Wipes

Urigel Wipes 450 each450 Each NDC:80924-110-03

ANTIBACTERIAL ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80924-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80924-110-03450 g in 1 CANISTER; Type 0: Not a Combination Product10/30/2020
2NDC:80924-110-0180 g in 1 CANISTER; Type 0: Not a Combination Product10/01/2020
3NDC:80924-110-02100 g in 1 CANISTER; Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2020
Labeler - Urigel (117688244)
Registrant - Urigel Inc (117688244)
Establishment
NameAddressID/FEIBusiness Operations
Antisépticos de México, S.A. de C.V.951576637manufacture(80924-110)

Revised: 1/2021
Document Id: b847ac3f-c09e-ecba-e053-2995a90ae43b
Set id: b8474a3f-a7c1-3723-e053-2a95a90a909f
Version: 5
Effective Time: 20210106
 
Urigel