ALCOHOL WIPES- sanitizing wipes cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

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

ALCOHOL 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._
----------
42003-206
ALCOHOL WIPES
ACTIVE INGREDIENT(S)
Ethyl Alcohol 75% v/v
PURPOSE
Antiseptic
USE
Decreases bacteria on the skin
WARNINGS
For external use only. Flarnmable. Keep av-,ay from heat or flarne.
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
Water
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
ALCOHOL WIPES
sanitizing wipes cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:42003-206
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Zhejiang Jiayan Daily Commodity Co., Ltd
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
75 mL in 100
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42003-206-
01
80 in 1 BAG; Type 0: Not a Combination
Product
09/05/2020
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333A
03/30/2020
LABELER -
Zhejiang Jiayan Daily Commodity Co., Ltd (679832147)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIO