DISINFECTANT WIPES (75% ALCOHOL)- ethanol cloth 
Jintu Handicraft Factory

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.

----------

JinTu, Wipes, 75% Ethanol

Active ingredient

Ethanol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

Do not use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Unfold towelette, wipe hands, discard after use.

Rub thoroughly into hands for at least 30 seconds, allow to dry.

Directions

Peel back flap on front to pull out a wipe.

Unfold and wipe hands thoroughly.

Reseal and let hands dry.

No need to rinse.

Warnings

For external use only. Flammable. Keep away from heat or flame

Other information

Store between 15-30℃ (59-86℉)

Inactive ingredients

glycerin, purified water USP

Package label. Principal display panel

A-Pouch-100

DISINFECTANT WIPES (75% ALCOHOL) 
ethanol cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79846-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL3 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79846-101-2150 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
2NDC:79846-101-2360 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
3NDC:79846-101-2572 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
4NDC:79846-101-2780 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
5NDC:79846-101-31100 in 1 POUCH; Type 0: Not a Combination Product07/27/2020
6NDC:79846-101-50100 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
7NDC:79846-101-52120 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
8NDC:79846-101-56160 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
9NDC:79846-101-58180 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
10NDC:79846-101-60200 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
11NDC:79846-101-90500 in 1 PAIL; Type 0: Not a Combination Product07/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/27/2020
Labeler - Jintu Handicraft Factory (654443675)
Registrant - A03 Lab of BTS (548009541)
Establishment
NameAddressID/FEIBusiness Operations
Jintu Handicraft Factory654443675manufacture(79846-101) , label(79846-101)

Revised: 7/2020
Document Id: ab42f586-7b71-1f93-e053-2995a90af2e1
Set id: ab42f586-7b70-1f93-e053-2995a90af2e1
Version: 1
Effective Time: 20200725
 
Jintu Handicraft Factory