DENATURED ALCOHOL- ethanol liquid
Shantou Kangjie Daily Chemical Industry 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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74047-003 Denatured Alcohol

ACTIVE INGREDIENT

Ethyl Alcohol 75% v/v

Antimicrobial

Hand Sanitizer to help reduce bacteria on skin.

WARNING

Flammable liquid - Keep away from heat, spark, electrical, fire or flame.

Keep out of reach of children.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

When using this product,

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask doctor if irrtation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Conter right away.

Stop use and ask doctor if irrtation or rash appears and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Conter right away.

Place enough product in your palm to thoroughly spread on both hands.

Children under 6 years of age should be supervised when using this product.

INACTIVE INGREDIENT

Purified Water

003

DENATURED ALCOHOL
ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74047-003
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74047-003-32	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	06/06/2023

Labeler - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712)

Registrant - Shantou Kangjie Daily Chemical Industry Co.,Ltd (527128712)

Name	Address	ID/FEI	Business Operations
Establishment
Shantou Kangjie Daily Chemical Industry Co.,Ltd		527128712	manufacture(74047-003)

Revised: 6/2023

Document Id: fd5f7cfa-0603-ae9a-e053-6294a90aaed1

Set id: fd5f7cfa-0602-ae9a-e053-6294a90aaed1

Version: 1

Effective Time: 20230606

Shantou Kangjie Daily Chemical Industry Co.,Ltd