Antibacterial hand sanitizer

Antibacterial hand sanitizer by

Drug Labeling and Warnings

Antibacterial hand sanitizer by is a Otc medication manufactured, distributed, or labeled by Pluma Nacional S.a. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND SANITIZER- alcohol spray 
Pluma Nacional 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.

----------

Antibacterial hand sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 68%

Purpose

Antiseptic

Uses

  • For hand sanitizing

Warnings

For external use only hands.

Flammable. Keep away from heat or flame.

When using this product

Keep out of eyes.  In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

Keep out of reach of children

Other information:

store at 20°C (68° to 77° F). may discolor fabrics.

Ingreidients:

Glycerin, propylene glycol, triethanolamine, carbomer, fragrance, disodium edta, tocopheryl acetate, deionized water.

Package Labeling:

BottleLabel

ANTIBACTERIAL HAND SANITIZER 
alcohol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52381-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.68 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52381-000-0110 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/202012/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/01/202012/30/2022
Labeler - Pluma Nacional S.a. de C.V. (821213352)

Revised: 6/2022
Document Id: e296bb79-a51c-7ae8-e053-2995a90a925e
Set id: b0793e5b-63c6-652c-e053-2a95a90a464d
Version: 2
Effective Time: 20220629