HAND SANITIZING WIPES- alcohol patch 
ZheJiang HuaShun Technology 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.

----------

Active Ingredient(s)

Benzalkonium chloride 0.13%. Purpose: Antiseptic

Purpose

Antiseptic

USES

For sanitizing to decrease bacteria on skin

apply topically to the skin to help prevent cross contamination

recommended for repeated use

dries in seconds

Warnings

For external use only.

May irritate eyes

Keep out of reach of children unless under adult supervision

Keep out of reach of children unless under adult supervision

Inactive ingredients

Water, Propylene Glycol,Disodium EDTA,Chloro-methyl-isothiazolinone and Methyl-isothiazolinone,Potassium Sorbate,Quatermium-15,Aloe Barbadensis Leaf Juice,Disodium Cocoamphodiacetate,Vitamin E Acetate,Polysorbate-20,Citric Acid,Fragrance.

Package Label - Principal Display Panel

image descriptionimage descriptionimage descriptionimage description

HAND SANITIZING WIPES 
alcohol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77046-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) (METHYLCHLOROISOTHIAZOLINONE - UNII:DEL7T5QRPN) METHYLCHLOROISOTHIAZOLINONE0.0009 g  in 100 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.0003 g  in 100 g
BRONOPOL (UNII: 6PU1E16C9W) (BRONOPOL - UNII:6PU1E16C9W) BRONOPOL0.03 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.02 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.50 g  in 100 g
POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.15 g  in 100 g
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) 0.15 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.20 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.05 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g  in 100 g
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.02 g  in 100 g
WATER (UNII: 059QF0KO0R) 98.7 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77046-009-011 in 1 PACKAGE09/21/2020
14 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:77046-009-0230 in 1 PACKAGE09/21/2020
24 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/21/2020
Labeler - ZheJiang HuaShun Technology Co.,Ltd (527157837)
Establishment
NameAddressID/FEIBusiness Operations
ZheJiang HuaShun Technology Co.,Ltd527157837manufacture(77046-009)

Revised: 9/2020
Document Id: 42b4f186-020d-470e-b2e5-d13a2fce6265
Set id: d2b3627e-5606-45b1-9080-c9543b8462f0
Version: 1
Effective Time: 20200921
 
ZheJiang HuaShun Technology Co.,Ltd