ANTIBACTERIAL HAND SANITIZER- alcohol gel 
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 62%

Purpose

Antiseptic

Uses:

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

Warnings:

For external use only.

Flammable. Keep away from heat and 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°-77°F). May discolor fabrics

Inactive Ingredients:

water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, carbomer, fragrance.

Package Labeling:15ml

Label

Package Labeling:30ml

Label2

Package Labeling:59ml

Box

ANTIBACTERIAL HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90121-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:90121-002-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
2NDC:90121-002-3030 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
3NDC:90121-002-5959 mL in 1 BOTTLE; Type 0: Not a Combination Product07/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/30/2020
Labeler - Sweda Company LLC (081729899)

Revised: 8/2020
Document Id: ae30f0a2-2010-8807-e053-2995a90a52b1
Set id: ad53f1de-1040-9804-e053-2995a90ad292
Version: 2
Effective Time: 20200831
 
Sweda Company LLC