Instant hand sanitizer by Pluma Nacional S.a. de C.V. Instant hand sanitizer

Instant hand sanitizer by

Drug Labeling and Warnings

Instant 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]

INSTANT 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.

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Instant hand sanitizer

Drug Facts

Active ingredient:

Ethyl Alcohol 68%

Purpose:

Antiseptic

Uses:

• Hand sanitizer reduce bacteria on skin

Warnings:

Flammable, Keep away from fire and flame.

For external use only

When using this product:

do not use in or near eyes, in case of contact, rinse eyes thoroughly with water.

Keep out of reach of children

Directions:

Place product on hands, rub untill dry

Ingreidients:

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

Package Labeling:

INSTANT HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52381-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.68 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52381-003-01	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/01/2020	06/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/01/2020	06/18/2022

Labeler - Pluma Nacional S.a. de C.V. (821213352)

Revised: 6/2022

Document Id: e297203f-8bf1-5c51-e053-2995a90a6242

34390-5

Set id: b0797e9a-5db3-c369-e053-2a95a90ae4ff

Version: 2

Effective Time: 20220629