ANTISEPTIC WIPES- sanitizing wipes cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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

Summary of Product characteristics

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._
----------
42003-208
ANTISEPTIC WIPES
ACTIVE INGREDIENT(S)
Benzalkonium chloride 0.13%
PURPOSE
Antiseptic
USE
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 TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42003-208
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6JUD5X6Y)
BENZ ALKONIUM
CHLORIDE
0.13 g
in 100
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PHENOXYETHANOL (UNII: HIE492ZZ3T)
Zhejiang Jiayan Daily Commodity Co., Ltd
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LEMON (UNII: 24RS0A988O)
WATER (UNII: 059QF0KO0R)
CETYLPYRIDINIUM CHL