Hand Sanitizer (70% Alcohol) Green apple fragrance

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Acenzia Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Acenzia 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.

----------

Hand Sanitizer (70% Alcohol)
Green apple fragrance

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  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.

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 70% 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

  • 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, carbomer, triethanolamine (trolamine), Fragrance (Green apple), purified water USP

Package Label - Principal Display Panel

1 L3.78 L500 mL label500 mL NDC: 78698-003-02

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78698-003
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
FRAGRANCE GREEN APPLE ORC2001072 (UNII: U9GH30P956) 0.66 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 0.735 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK) 0.619 mL  in 100 mL
CARBOMER 934 (UNII: Z135WT9208) 4.76 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78698-003-02500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/19/202006/19/2020
2NDC: 78698-003-033780 mL in 1 JUG; Type 0: Not a Combination Product06/19/202006/19/2020
3NDC: 78698-003-041000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/19/202006/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/19/202006/19/2020
Labeler - Acenzia Inc (201549504)
Registrant - Acenzia Inc (201549504)
Establishment
NameAddressID/FEIBusiness Operations
Acenzia Inc201549504manufacture(78698-003)

Revised: 11/2021
 

Trademark Results [Hand Sanitizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAND SANITIZER
HAND SANITIZER
88958909 not registered Live/Pending
MAISON BLANCHE, LLC
2020-06-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.