75 ALCOHOL WIPES- alcohol cloth 
Newacme LLC

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

Drug Facts

Active Ingredient

Ethyl alcohol 75%

Purpose

Antibacterial

Uses

To decrease bacteria on the skin that could cause disease. Recommended to use repeatedly.

Warnings

For external use only.

please put in a cool and dry place avoid direct sunlight and very warm temperature.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.

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

Directions

Wet skin thoroughly with this products and allow to dry. Discard wipes in a recyclable trash can after use.

Inactive Ingredients

Butane-1,3-diol, Glycerol, Pure water, Aloe extract

Package Labeling:

Label

75 ALCOHOL WIPES 
alcohol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74341-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.75 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:74341-018-0120 in 1 BAG07/10/2020
14.25 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/10/2020
Labeler - Newacme LLC (117465743)
Establishment
NameAddressID/FEIBusiness Operations
Baijieyuan Biotechnology (Shandong) Co., Ltd.554531114manufacture(74341-018)

Revised: 7/2020
Document Id: aaf1900c-a49a-e4a8-e053-2a95a90a2a14
Set id: d37025d8-5579-4a1c-8637-4ed5f94e0afe
Version: 1
Effective Time: 20200721
 
Newacme LLC