NON ALCOHOL HAND SANITIZER- non alcohol hand sanitizer liquid 
Uweport LLC

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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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. Benzalkonium Chloride ( 0.13% w/v).
  2. Coco-Glucoside (1.5% v/v).
  3. Laurtrimonium Chloride (0.3% v/v).
  4. Cocamidopropylamine Oxide (0.3% v/v).
  5. 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)

Benzalkonium Chloride 0.13% w/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

Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, purified water USP

Package Label - Principal Display Panel

Non alcohol hand sanitizer1000 ml NDC: 80401-102-10

NON ALCOHOL HAND SANITIZER 
non alcohol hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80401-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK) 0.3 mL  in 100 mL
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC) 0.3 mL  in 100 mL
COCO GLUCOSIDE (UNII: ICS790225B) 1.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80401-102-101000 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 finalpart333A03/30/2020
Labeler - Uweport LLC (081252924)
Registrant - Uweport llc (081252924)
Establishment
NameAddressID/FEIBusiness Operations
Uweport081252924label(80401-102)
Establishment
NameAddressID/FEIBusiness Operations
Guangdong Bolicen Bio-Technology Co Ltd554525110manufacture(80401-102)

Revised: 10/2020
Document Id: b0f835bc-f0d2-9cea-e053-2995a90aaad3
Set id: b09fc90f-d11b-9c24-e053-2a95a90a4b0a
Version: 2
Effective Time: 20201005
 
Uweport LLC