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., ABSOLUT DISTILLERS, INC.. 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]

Alcohol 80% 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 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 (104F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Manufactured by
ABSOLUT DISTILLERS, INC.
Malaruhatan, Lian, Batangas, Philippines

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

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label

ALCOGENIX™
ALCOHOL ANTISEPTIC 80%

TOPICAL SOLUTION
HAND SANITIZER

NON-STERILE SOLUTION
Formulated consistent with the US Food and Drug Administration's
& the World Health Organization's Guidelines

1 GALLON (128 fl. oz. / 3.78 L)

PRINCIPAL DISPLAY PANEL - 3.78 L Bottle Label
ALCOGENIX ANTISEPTIC HAND SANITIZER 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 90046-503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
glycerin (UNII: PDC6A3C0OX)  
hydrogen peroxide (UNII: BBX060AN9V)  
water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 90046-503-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/202012/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333A10/01/202012/31/2021
Labeler - TANDUAY DISTILLERS INC. (718851876)
Establishment
NameAddressID/FEIBusiness Operations
ABSOLUT DISTILLERS, INC.718866569MANUFACTURE(90046-503)

Revised: 7/2022
Document Id: 81a1e599-9832-473f-b7c6-eda712d1376c
Set id: 02aa0390-7ec9-4411-8565-afa9a0767e68
Version: 2
Effective Time: 20220711