WIPES cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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