SANITIZER WIPES- ethyl alcohol solution 
Audy Global Enterprises Inc.

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.

----------

Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Purpose

Purpose: Antimicrobial

Use

Sanitizer Wipes 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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Directions

Wipe surface to be disinfected.

Supervise children under 12 years of age when using this product to avoid swallowing.

Other information

Inactive ingredients

Water Glycerol, Aloe. Vera, Chamomile Oil, D-Glucopyranose, Oligomeric, Benzethonium Chloride, Cetylpyridinium Chloride, Didecyldimethylammonium Chloride

Package Label - Principal Display Panel

300 units NDC:75778-004-30

300 Wipes

SANITIZER WIPES 
ethyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75778-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75   in 100 
Inactive Ingredients
Ingredient NameStrength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y) 0.1 
CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S) 0.05 
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) 0.04 
GLYCERIN (UNII: PDC6A3C0OX) 0.5 
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.3 
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839) 0.2 
BENZETHONIUM CHLORIDE (UNII: PH41D05744) 0.08 
WATER (UNII: 059QF0KO0R) 23.73 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75778-004-30300 in 1 CARTON; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - Audy Global Enterprises Inc. (079171473)
Establishment
NameAddressID/FEIBusiness Operations
ENPING JIAXIN DAILY NECESSITIES CO.,LTD.403010421manufacture(75778-004)

Revised: 5/2020
Document Id: a6ac4c67-240f-91a4-e053-2995a90a197e
Set id: a6acd1d9-4fae-692a-e053-2a95a90a5697
Version: 1
Effective Time: 20200527
 
Audy Global Enterprises Inc.