ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
Orange (Fujian) Sanitary Products 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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81614-015-20 81614-015-50 Antibacterial Hand Wipes
Benzalkonium Chloride

Active Ingredient(s)

BENZALKONIUM CHLORIDE 0.15% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Antibacterial Hand Wipes

Use

USES:Single use wipes to cleanse hands and help prevent the spread of bacteria.

Warnings

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.
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.

If irritation and redness develop. If condition continues, consult your health care practitoner.

Directions

Other information

Inactive ingredients

WATER,ALOE EXTRACT,SODIUM PHENYLKALATE

Package Label - Principal Display Panel

20 cloth NDC: 81614-015-20

20 cloth label

50 cloth NDC: 81614-015-50

50 CLOTH LABEL

ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81614-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE (UNII: V5VD430YW9)  
SODIUM PHENYLLACTATE (UNII: KYI2U2BS89)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81614-015-2020 in 1 PACKAGE02/17/2021
15.75 g in 1 PATCH; Type 0: Not a Combination Product
2NDC:81614-015-5050 in 1 PACKAGE02/17/2021
26 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 finalpart333A02/17/2021
Labeler - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
Registrant - Orange (Fujian) Sanitary Products Co., Ltd. (715236216)
Establishment
NameAddressID/FEIBusiness Operations
Orange (Fujian) Sanitary Products Co., Ltd.715236216manufacture(81614-015)

Revised: 2/2021
Document Id: bbbb933e-34a9-143a-e053-2995a90a7c91
Set id: bbbb93d9-218f-3f83-e053-2995a90afde7
Version: 1
Effective Time: 20210219
 
Orange (Fujian) Sanitary Products Co., Ltd.