HAND SANITIZER- hand sanitizer gel 
Dongguan Boze Technology Co., LTD

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 sanitizer

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 (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (0.4% v/v).
  3. Carbomer (0.35% v/v).
  4. Sterile distilled water or boiled cold water.
  5. Propanediol.
  6. Polyacrylic acid.
  7. Triethanolamine.

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)

Isopropyl Alcohol 75% 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

30 ml in 1 bottle NDC: 78634-001-01

30ML Label

60 ml in 1 bottle NDC: 78634-001-02

60ML Label

HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78634-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75.12 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 0.4 mL  in 100 mL
PROPANEDIOL (UNII: 5965N8W85T) 0.26 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 23.3 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.35 mL  in 100 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.28 mL  in 100 mL
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) 0.29 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78634-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
2NDC:78634-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/01/2020
Labeler - Dongguan Boze Technology Co., LTD (554535587)
Registrant - Dongguan Boze Technology Co., LTD (554535587)
Establishment
NameAddressID/FEIBusiness Operations
Dongguan Boze Technology Co., LTD554535587manufacture(78634-001)

Revised: 5/2020
Document Id: a6cc2754-5bf7-4fff-e053-2995a90a0173
Set id: a7076e7a-395b-eb11-e053-2995a90a956d
Version: 1
Effective Time: 20200529
 
Dongguan Boze Technology Co., LTD