HAND SANITIZER- alcohol liquid 
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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Lemon Hand Sanitizer 80%

The hand sanitizer is manufactured using only the following ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.
  5. fragrance

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.

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 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

  • 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

glycerin, hydrogen peroxide, purified water USP, fragrance

Package Label - Principal Display Panel

55 gallons NDC: 75009-480-01

208190 ml label

275 gallons NDC: 75009-480-02

1040980 ml label

5 gallons NDC: 75009-480-03

18920 ml label

1 gallon NDC: 75009-480-04

3780 ml label

1 quart NDC: 75009-480-05

946 ml label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-480
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) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
CITRAL (UNII: T7EU0O9VPP) 1.11 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75009-480-01208190 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
2NDC:75009-480-021040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
3NDC:75009-480-0318920 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
4NDC:75009-480-043780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
5NDC:75009-480-05946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/202003/30/2021
Labeler - Alpha Aromatics (041723545)
Establishment
NameAddressID/FEIBusiness Operations
Alpha Aromatics041723545manufacture(75009-480)

Revised: 11/2022
Document Id: ee88c9b1-4222-c1cf-e053-2995a90a7296
Set id: a4ffb1b5-a569-1520-e053-2995a90a71a0
Version: 3
Effective Time: 20221128
 
Alpha Aromatics