Alcogenix™ antiseptic hand sanitizer

Alcogenix antiseptic hand sanitizer by

Drug Labeling and Warnings

Alcogenix antiseptic hand sanitizer by is a Otc medication manufactured, distributed, or labeled by TANDUAY DISTILLERS INC., ALLTRADE MARKETING AND MANUFACTURING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOGENIX ANTISEPTIC HAND SANITIZER- alcohol solution 
TANDUAY DISTILLERS 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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Alcogenix™ antiseptic hand sanitizer

Drug Facts

Active Ingredient[s]

Ethyl Alcohol 62% v/v

Purpose

Antiseptic

Use [s]

Hand Sanitizer to help reduce 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

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

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 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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Polyacrylate Crosspolymer-6, PPG-26-buteth-26, PEG-40 Hydrogenated Castor Oil, Saccharide Isomerate, Tocopheryl Acetate, Fragrance

Manufactured by
ALLTRADE MARKETING AND MANUFACTURING CORP.
9056 PVR Compound. DRT Highway, Tangos, Baliuag,
Bulacan, Philippines

Distributed by
MIDWAY TRADING CORPORATION
130 Battery Street, San Francisco CA 94111

PRINCIPAL DISPLAY PANEL - 600 ml Bottle Label

ALCOGENIX™

HAND SANITIZER GEL

ALCOHOL ANTISEPTIC 62 %

with
E
VITAMIN
& PLANT-BASED
MOISTURIZING
INGREDIENT*

PRODUCT OF THE PHILIPPINES

20.3 FL OZ (600 ml)

Principal Display Panel - 600 ml Bottle Label
ALCOGENIX ANTISEPTIC HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 90046-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
PPG-26-buteth-26 (UNII: 2II1K6TZ4P)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Saccharide Isomerate (UNII: W8K377W98I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 90046-504-02600 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/202006/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A12/01/202006/30/2022
Labeler - TANDUAY DISTILLERS INC. (718851876)
Establishment
NameAddressID/FEIBusiness Operations
TANDUAY DISTILLERS INC.718851876API MANUFACTURE(90046-504)
Establishment
NameAddressID/FEIBusiness Operations
ALLTRADE MARKETING AND MANUFACTURING727668926MANUFACTURE(90046-504)

Revised: 2/2023
Document Id: b639f6ac-c35d-4ff8-8b73-bd9cfb8e5daa
Set id: f027b05c-1608-4075-bf84-c3d8381beeef
Version: 2
Effective Time: 20230214