75% Alcohol Wipes by Zhejiang Lake Products Co.,Ltd 75% Alcohol Wipes

75% Alcohol Wipes by

Drug Labeling and Warnings

75% Alcohol Wipes by is a Otc medication manufactured, distributed, or labeled by Zhejiang Lake Products Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

75% ALCOHOL WIPES- alcohol cloth 
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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75% Alcohol Wipes

Active Ingredient(s)

Alcohol 75%

Benzalamine

2-methyl-4-isothiazoline-3-one

Purpose: Antiseptic

Purpose

Antiseptic, wet wipe

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

Wipe the surface of the object
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

purified water USP

Package Label - Principal Display Panel

80pcs NDC: 78616-002-02

75% ALCOHOL WIPES 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78616-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZYLAMINE (UNII: A1O31ROR09) (BENZYLAMINE - UNII:A1O31ROR09)	BENZYLAMINE	0.1 mg  in 100 mL
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA)	METHYLISOTHIAZOLINONE	0.1 mg  in 100 mL
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: 78616-002-01	10 mL in 1 BAG; Type 0: Not a Combination Product	06/09/2020
2	NDC: 78616-002-02	16 mL in 1 BAG; 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	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(78616-002)

Revised: 11/2021

Document Id: d177338d-5ac2-3099-e053-2a95a90aec6d

34390-5

Set id: a7e03089-d1bb-797c-e053-2995a90a48fc

Version: 2

Effective Time: 20211123