DUGEL- sanitizer gel 
DUTRIEC S.A.

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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DUTRIEC SA-DUGEL Sanitizer Pouch

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce the bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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 right away.

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 right away.

Directions

Other information

Inactive ingredients

carbomer interpolymer, citrus, Tocopherol, glycerin, trolamine, purified water

Package Label - Principal Display Panel

2 mL NDC: 80549-111-112 mL NDC: 80549-111-12

DUGEL 
sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80549-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ORANGE OIL (UNII: AKN3KSD11B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80549-111-112.5 mL in 1 POUCH; Type 0: Not a Combination Product09/17/2020
2NDC:80549-111-122 mL in 1 POUCH; Type 0: Not a Combination Product02/03/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/17/2020
Labeler - DUTRIEC S.A. (955048863)
Establishment
NameAddressID/FEIBusiness Operations
DUTRIEC S.A.955048863manufacture(80549-111)

Revised: 12/2021
Document Id: d44bc82e-6210-7f35-e053-2995a90addb4
Set id: af84c4b5-e233-711d-e053-2995a90a0cab
Version: 3
Effective Time: 20211229
 
DUTRIEC S.A.