ANTIBACTERIAL HAND SANITIZER- alcohol gel

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]

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

Package Labeling:30ml

Package Labeling:59ml

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90121-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.62 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90121-002-15	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
2	NDC: 90121-002-30	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020
3	NDC: 90121-002-59	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/30/2020

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

Labeler - Sweda Company LLC (081729899)