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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78959-001
ALCOHOL WIPES

Active Ingredient

Ethyl alcohol 75%.v/v

Purpose

Antimicrobial

Use

decreases bacteria on skin.

Warnings

For external use only.

Flammable.Keep away from fire or flame.

Do not use

if you are allergic to any of the ingredients.

When using this product

do not get into eyes.In case of contact,rinse thoroughly with water.

Stop use and ask doctor

if irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

Adults and children apply to hands.

Children under 6 years of age should be supervised when using HY 2 years and over.

Other information

Inactive Ingredients

Ro pure water, Double-chain quaternary ammonium salt.

Package Label - Principal Display Panel

78959-001-05 8078959-001-0178959-001-0278959-001-03 178959-001-03 278959-001-0478959-001-0678959-001-07 178959-001-07 278959-001-08

ALCOHOL WIPES 
alcohol wipes cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78959-001
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
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78959-001-011 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
2NDC:78959-001-0210 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
3NDC:78959-001-0350 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
4NDC:78959-001-0460 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
5NDC:78959-001-0580 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
6NDC:78959-001-06100 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
7NDC:78959-001-0760 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
8NDC:78959-001-0880 in 1 BAG; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/16/2020
9NDC:78959-001-09100 in 1 BAG; 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(78959-001)

Revised: 12/2020
Document Id: b62bf709-3688-36d4-e053-2a95a90add7b
Set id: a83c473b-d5ac-65cb-e053-2a95a90a05a1
Version: 6
Effective Time: 20201211
 
Weifang Yujie Disinfectant Co. , Ltd.