Antibacterial Hand Sanitizer

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Sweda Company LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL HAND SANITIZER- alcohol spray 
Sweda Company LLC

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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Antibacterial Hand Sanitizer

Drug Facts

Active Ingredients

Ethyl Alcohol 72%

Purpose

Antiseptic

Uses:

Hand sanitizer to help decrease bacteria on the skin. When water, soap & towel are not available. Recommended for repeated use.

Warnings:

For external use only.

Flammable. Keep away from fire or flame. Do not apply around eyes, 

Do not use

in ears & mouth.

When using this product,

avoid contact with eyes. In case of contact flush eyes with water.

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours.

Keep out of reach of children.

Children must be supervised in use of this product.

Directions:

Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry.

Other Information:

Store at 20° C (68° to 77° F). May discolor fabrics

Inactive Ingredients:

water

Package Labeling:

ANTIBACTERIAL HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90121-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	72 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90121-004-01	2.5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020	12/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/30/2020	12/30/2022

Labeler - Sweda Company LLC (081729899)

Revised: 1/2022

Document Id: d4b08741-d934-9423-e053-2a95a90a010b

34390-5

Set id: bb79329d-d5b5-631f-e053-2a95a90af781

Version: 2

Effective Time: 20220103