PRO CLEAN ALCOHOL WIPES- alcohol wipes cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Shandong Oushile Biotechnology Co.Ltd

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Ethyl Alcohol   Antiseptic Helps reduce bacteria that potentially can cause disease. - in children 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 serious condition.

Authorization status:

OTC monograph not final

Summary of Product characteristics

PRO CLEAN ALCOHOL WIPES- ALCOHOL WIPES CLOTH
SHANDONG OUSHILE BIOTECHNOLOGY 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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SHANDONG OUSHILE BIOTECHNOLOGY CO.LTD
ACTIVE INGREDIENT
Ethyl Alcohol 75% v/v
PURPOS E
Ethyl Alcohol Antiseptic
US E
Helps reduce bacteria that potentially can cause disease.
WARNINGS
For external use only. Flammable. Keep away from heat or flame.
DO NOT USE
in children 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
Stop use and ask a doctor if irritation or rash occurs. These may be
signs of a serious condition.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Open the package and wipe skin until dry.
Supervise children under 6 years of age when using this product to
avoid swallowing.
OTHER INFORMATION
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)
MANUFACTURED BY SHANDONG OUSHILE BIOTECHNOLOGY CO.LTD
Made in China
Distributed by Bigbattery, Inc
9667 Owensmouth Ave, Chatsworth, CA 91311
Phone: [phone]
[e-mail]
INACTIVE INGREDIENTS
CETYLPYRIDINIUM CHLORIDE, WATER
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
PRO CLEAN ALCOHOL WIPES
alcohol wipes cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:78 78 1-311
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
75 mL in 10 0
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P)
WATER (UNII: 0 59 QF0 KO0 R)
Shandong Oushile Biotechnology Co.Ltd
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1