Hand Sanitizer by Zhejiang Lake Products Co.,Ltd Hand sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Lake Products Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Zhejiang Lake Products 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

Active Ingredient(s)

carbomer

triethanolamine

Alcohol

Purpose

Antiseptic, Hand Sanitizer

Warnings

Not for use on children less than 2 months old. Children under 6 years of age should be supervised when using to avoid swallowing. Do not use on open skin wounds.

Avoid contacting face, eys and broken skin. In case of eye contact, flush repeatedly with water and seek medical assistance.

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 between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

water, carbomer, Triethanolamine

Place enough gel into your palm to thoroughly spread on both hands (front & back) and rub into the skin until dry.Children should be supervised when using this product.

Package Label - Principal Display Panel

60 mL NDC: 78616-001-01

250 mL NDC: 78616-001-02

1000 mL NDC: 78616-001-03

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78616-001
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.4 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.3 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78616-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
2	NDC: 78616-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020
3	NDC: 78616-001-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/02/2020	11/22/2021

Labeler - Zhejiang Lake Products Co.,Ltd (548230777)

Registrant - Zhejiang Lake Products Co.,Ltd (548230777)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Lake Products Co.,Ltd		548230777	manufacture(78616-001)

Revised: 11/2021

Document Id: d1772bd0-4de8-6492-e053-2995a90a5254

34390-5

Set id: a753c1e0-73c2-44b2-e053-2a95a90ae401

Version: 2

Effective Time: 20211123