WIPES cloth

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)
Available from:
Huihao Medical Technology (Zhejiang) Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for hand sanitizing to decrease bacteria on skin safe for repeated use / Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72hours
Authorization status:
OTC monograph not final
Authorization number:
77909-010-01, 77909-010-02

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WIPES- wipes cloth

Huihao Medical Technology (Zhejiang) 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.

----------

77909-010

Wipes

Active Ingredient(s)

Benzalkoniu m Chlloridle O.13%

Purpos e

Us e

for hand sanitizing to decrease bacteria on skin

safe for repeated use

Warnings

For exter1nal use onlly

Do not use

When using this p1rodlu1ct avoid contact with eyes. If in1e yes, flush thoroughly with water

Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more

than 72hours

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

away

Directions

peel back label

remove and un1fold wipes

wipe hands thoroughly for approximately 30seconds

dispose of used wipes in trash, do not flush.

Other information

Inactive ingredients

Glycerin, Aloe Vera, Vitamin E, Purified Water

Package Label - Principal Display Panel

WIPES

wipes cloth

Huihao Medical Technology (Zhejiang) Co., Ltd

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:779 0 9 -0 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -

UNII:7N6 JUD5X6 Y)

BENZALKONIUM

CHLORIDE

0 .13 g

in 10 0

Inactive Ingredients

Ingredient Name

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX)

ALPHA-TO CO PHERO L (UNII: H4N8 55PNZ1)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:779 0 9 -0 10 -0 1

10 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /20 20

2

NDC:779 0 9 -0 10 -0 2

50 in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

0 3/30 /20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 3/30 /20 20

Labeler -

Huihao Medical T echnology (Zhejiang) Co., Ltd (541292810)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Huihao Medical Techno lo gy (Zhejiang) Co ., Ltd

54129 28 10

ma nufa c ture (779 0 9 -0 10 )

Revised: 11/2020

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