Ni Hua 2nd submittal 008-04

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ni Hau Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Ni Hau Industrial 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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Ni Hua 2nd submittal 008-04

Active Ingredient(s)

Alcohol 75%

Purpose

Antiseptic

Use

For hand sanitizing to reduce bacteria on the skin

Warnings

For external use only. Flammable, keep away for fire and flames.

When using this product keep out of eyes. In case of eye contact, flush with water. Do not inhale or ingest.

Stop Use and ask a doctor if skin irritation develops.

Keep out of the reach of children

Directions

Squeeze a sufficient amount on hands. Rub together until dry.

Inactive ingredients

Water, Propanediol, Polyacrylic Acid, Triethanolamine, Cyclohexane

Package Label - Principal Display Panel

4 mL NDC: 77189-008-04

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77189-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOHEXANE (UNII: 48K5MKG32S)
PROPANEDIOL (UNII: 5965N8W85T)
TRIETHANOLAMINE 2-CYCLOHEXYL-4,6-DINITROPHENOLATE (UNII: N2TK31JIAH)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77189-008-04	4 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/09/2020	12/01/2022

Labeler - Ni Hau Industrial Co., Ltd. (658274464)

Establishment
Name	Address	ID/FEI	Business Operations
Ni Hau Industrial Co., Ltd.		658274464	manufacture(77189-008)

Revised: 12/2022

Document Id: f1267d74-cfbe-9005-e053-2995a90a23cd

34390-5

Set id: a7b2d711-8691-3db2-e053-2a95a90aaf73

Version: 4

Effective Time: 20221231