ANTISEPTIC WIPES- sanitizing 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:
Zhejiang Jiayan Daily Commodity Co., Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Decreases bacteria on the skin in childr&n less than 2 months of age on open skin wounds Stop use and ask a doctor if irritation or rash occurs. These may be signs of a sefious condition.
Authorization status:
OTC monograph not final
Authorization number:
42003-208-01, 42003-208-02

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ANTISEPTIC WIPES- sanitizing wipes cloth

Zhejiang Jiayan Daily Commodity 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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42003-208

ANTISEPTIC WIPES

Active Ingredient(s)

Benzalkonium chloride 0.13%

Purpos e

Antiseptic

Us e

Decreases bacteria on the skin

Warnings

KEEP OUT OF REACH OF CHILDREN . FOR EXTERNAL USE ONLY . KEEP OUT OF EYES

AND MOUTH . STOP USE IF YOU FEEL UNWELL OR IRRITATED

Do not use

in childr&n less than 2 months of age

on open skin wounds

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 sefious condition.

Keep out of reach o1 children. If swallowed, get medical help or contact Poison Control Center right

away.

Directions

Open package. Pull wipe. Close package to retain moisture

Wet hands thoroughly with product.

Allow to dry without rinsing.

Other information

store between 15-30C (59-86F)

Avoid freezing and exessive heat aboce 40C (104F)

Inactive ingredients

Cetylpyrdinium chloride, Propylene Glycol, 2-phenoxyethanol, Disodium EDTA., Citric Acid,

Fragrance, Aloe Barbadensis Leaf Juice, Water.

Package Label - Principal Display Panel

ANTISEPTIC WIPES

sanitizing wipes cloth

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:420 0 3-20 8

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

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

Zhejiang Jiayan Daily Commodity Co., Ltd

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

LEMO N (UNII: 24RS0 A9 8 8 O)

WATER (UNII: 0 59 QF0 KO0 R)

CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)

CHAMO MILE (UNII: FGL36 8 5T2X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:420 0 3-20 8 -0 1

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

0 9 /0 5/20 20

2

NDC:420 0 3-20 8 -0 2

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

0 9 /0 5/20 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 -

Zhejiang Jiayan Daily Commodity Co., Ltd (679832147)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Zhejiang Jiayan Daily Co mmo dity Co ., Ltd

6 79 8 32147

ma nufa c ture (420 0 3-20 8 )

Revised: 12/2020

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