HAND SANITIZER GEL- ethyl alcohol gel 
Tekna Fill, Inc.

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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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

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

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

Directions

Other information

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

60 mL

HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77183-8067(NDC:73809-8067)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL61 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
WATER (UNII: 059QF0KO0R)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
TROLAMINE (UNII: 9O3K93S3TK)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77183-8067-10.0025 L in 1 BOX; Type 0: Not a Combination Product06/03/202006/03/2020
2NDC:77183-8067-224 in 1 BOX06/10/2020
20.0025 L in 1 POUCH; Type 0: Not a Combination Product
3NDC:77183-8067-3500 in 1 BOX06/10/2020
30.0025 L in 1 POUCH; Type 0: Not a Combination Product
4NDC:77183-8067-42500 in 1 BOX06/10/2020
40.0025 L in 1 POUCH; Type 0: Not a Combination Product
5NDC:77183-8067-51000 in 1 BOX06/10/2020
50.0025 L in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/03/2020
Labeler - Tekna Fill, Inc. (081509076)
Establishment
NameAddressID/FEIBusiness Operations
Tekna Fill, Inc.081509076repack(77183-8067)

Revised: 6/2020
Document Id: a93dbc45-1e81-1bfd-e053-2a95a90afc92
Set id: a61a453f-cbdf-6ea6-e053-2a95a90ab94e
Version: 2
Effective Time: 20200629
 
Tekna Fill, Inc.