HAND SANITIZING GEL- alcohol gel 
Alpha Aromatics

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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Hand Sanitizing Gel 62% (v/v)

The hand sanitizer is manufactured in accordance with the recommendations in 21 CFR Part 333 for alcohol based topical antimicrobial OTC products for human use.

  1. Alcohol(Ethanol) 62% (v/v).
  2. Sorbitol 0.6% (v/v).
  3. Gylcerin 0.6% (v/v).
  4. PEG-27 copolymer 0.375% (v/v)
  5. Triethanol 0.7% (v/v)
  6. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

203000 mL NDC: 75009-162-01

203000 ml label

868300 mL NDC: 75009-162-02

868300 ml label

HAND SANITIZING GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-162
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
TROLAMINE (UNII: 9O3K93S3TK) 0.7 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.6 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J) 0.375 mL  in 100 mL
SORBITOL SOLUTION (UNII: 8KW3E207O2) 0.6 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75009-162-01203000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:75009-162-02868300 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Alpha Aromatics (041723545)
Establishment
NameAddressID/FEIBusiness Operations
Alpha Aromatics041723545manufacture(75009-162)

Revised: 4/2020
Document Id: a4879519-ed52-25b8-e053-2a95a90a4693
Set id: a487a584-619d-5567-e053-2995a90a3c93
Version: 1
Effective Time: 20200430
 
Alpha Aromatics