ANTIBACTERIAL ALCOHOL WIPES- alcohol cloth 
Antisépticos de México, 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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Urigel Antibacterial 70% Alcohol wipes

Active Ingredient(s)

EthylAlcohol 70%. 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: Urigel Antibacterial 70% Alcohol Wipes 80 units

80 Wipes 80 units NDC: 76554-110-01

Principal Display Panel: Urigel Antibacterial 70% Alcohol Wipe 100 Units.

100 Wipes100 units. NDC: 76554-110-02

Principal Display Panel: Urigel Antibacterial 70% Alcohol Wipe 450 each

450 Units NDC 76554-110-03 450 Wipes

ANTIBACTERIAL ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76554-110
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:76554-110-0180 g in 1 CONTAINER; Type 0: Not a Combination Product10/30/2020
2NDC:76554-110-02100 g in 1 CONTAINER; Type 0: Not a Combination Product11/02/2020
3NDC:76554-110-03450 g in 1 CONTAINER; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/30/2020
Labeler - Antisépticos de México, S.A. de C.V. (951576637)
Registrant - Antisépticos de México, S.A. de C.V. (951576637)
Establishment
NameAddressID/FEIBusiness Operations
Antisépticos de México, S.A. de C.V.951576637manufacture(76554-110)

Revised: 11/2020
Document Id: b4f6a4cb-d31e-a8a1-e053-2a95a90a2773
Set id: b2ed5caf-d9a4-2372-e053-2995a90a105c
Version: 5
Effective Time: 20201125
 
Antisépticos de México, S.A. de C.V.