ALCOHOL WIPES- alcohol wipes cloth 
Weifang Yujie Disinfectant 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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78959-002
ALCOHOL WIPES

Active Ingredient

Ethanol 75%

Purpose

Antiseptic

Use

Wipe on skin to help reduce bacteria on skin that potentially can cause diseas

Warnings

For external use only
Flammable, keep away from heat or fame

Do not use

On children less than 2 montns of age

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 doctor

irritation or rash occurs, These may be signs of a senous condition.

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away

Directions

Rub hands on wipe
and use to disinfect
Supervise children under 6 years of age when using ths product.

Other information

Store below 43C (110F

Inactive Ingredients

aloe vera extract, glycerol, purified water.

Package Label - Principal Display Panel

78959-002-03 578959-002-04 10150

ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78959-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78959-002-011 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
2NDC:78959-002-0250 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
3NDC:78959-002-035 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
4NDC:78959-002-0410 in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/16/2020
Labeler - Weifang Yujie Disinfectant Co. , Ltd. (545098868)
Registrant - Weifang Yujie Disinfectant Co. , Ltd. (545098868)
Establishment
NameAddressID/FEIBusiness Operations
Weifang Yujie Disinfectant Co. , Ltd.545098868manufacture(78959-002)

Revised: 9/2020
Document Id: af434297-54a7-4a31-e053-2995a90a8f68
Set id: aadca2ba-90ff-5a7f-e053-2a95a90a100a
Version: 3
Effective Time: 20200914
 
Weifang Yujie Disinfectant Co. , Ltd.