HAND SANITIZER GEL- ethyl alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

Hand Sanitizer Gel by is a Otc medication manufactured, distributed, or labeled by Tekna Fill, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Active Ingredient(s)

Ethyl Alcohol 61% v/v. Purpose: Antimicrobial

Purpose

Antimicrobial, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria and viruses on the skin which could cause illness or disease. Recommended for repeated use.

Warnings

Flammable. Keep away from heat or flame.

For external use only

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if redness or irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

• Apply enitre package contents onto hands and rub until dry.
• Children under 6 years of age should be supervised when using this product.

Other information

• Store below 110 o F (43 o C)
• May discolor certain fabrics or surfaces
• www.ViRlogix.com

Inactive ingredients

Purified Water, Glycerol, Carbomer 940, Hydrogen Peroxide, Trolamine, Eucalyptus Oil

Package Label - Principal Display Panel

NDC: 77183-8067-2

24 POUCHES in 1 BOX > .0025L in 1 POUCH

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77183-8067(NDC:73809-8067)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	61 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
TROLAMINE (UNII: 9O3K93S3TK)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77183-8067-1	0.0025 L in 1 BOX; Type 0: Not a Combination Product	06/03/2020	06/03/2020
2	NDC: 77183-8067-2	24 in 1 BOX	06/10/2020
2		0.0025 L in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 77183-8067-3	500 in 1 BOX	06/10/2020
3		0.0025 L in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 77183-8067-4	2500 in 1 BOX	06/10/2020
4		0.0025 L in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 77183-8067-5	1000 in 1 BOX	06/10/2020
5		0.0025 L in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/03/2020

Labeler - Tekna Fill, Inc. (081509076)

Establishment
Name	Address	ID/FEI	Business Operations
Tekna Fill, Inc.		081509076	repack(77183-8067)