Hung Ru 001-01, 001-02 ans 001-03

Shanon Hand Sanitizer by

Drug Labeling and Warnings

Shanon Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hung Ru Enterprise Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SHANON HAND SANITIZER- alcohol liquid 
Hung Ru Enterprise 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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Hung Ru 001-01, 001-02 ans 001-03

Active Ingredient(s)

Alcohol 75%. 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, 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. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Other information

Store below 25C (77F)

Avoid freezing and excessive heat above 40C(104F)

Lot. No. and Manufacturing data can be found on bottle.

Inactive ingredients

purified water

Package Label - Principal Display Panel

500 mL NDC: 80333-001-02

SHANON HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80333-001
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
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80333-001-01	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020
2	NDC: 80333-001-02	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020
3	NDC: 80333-001-03	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/07/2020	08/22/2023

Labeler - Hung Ru Enterprise Co., Ltd. (656316184)

Establishment
Name	Address	ID/FEI	Business Operations
Hung Ru Enterprise Co., Ltd.		656316184	manufacture(80333-001)

Revised: 8/2023

Document Id: 0385a6b0-14c7-1c76-e063-6394a90a8df2

34390-5

Set id: aec164e7-20ed-433f-e053-2a95a90a8f94

Version: 5

Effective Time: 20230822