Shanon Hand Sanitizer by Hung Ru Enterprise Co., Ltd. Hung Ru 002-03

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- instant hand sanitizer gel 
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 002-03

Active Ingredient(s)

Alcohol 75% . Purpose: Antimicrobial

Purpose

Antimicrobial, 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 below 25C (77F)

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

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

500 mL NDC: 80333-002-03

SHANON HAND SANITIZER 
instant hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80333-002
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)
CARBOMER 1342 (UNII: 809Y72KV36)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80333-002-03	500 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(80333-002)

Revised: 8/2023

Document Id: 0385fb15-5608-e76c-e063-6394a90a2baf

34390-5

Set id: aec6367f-3fbb-63f4-e053-2995a90ab5af

Version: 4

Effective Time: 20230822