ANTIBACTERIAL HAND WIPES- biopure antibacterial hand wipes cloth

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

QUEST USA CORP

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial For Hand Sanitizer to decrease bacterial on the skin - in children less than 2 months of age - on open skin wounds Stop use and ask a doctor if irritation or rash appears and lasts

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL HAND WIPES- BIOPURE ANTIBACTERIAL HAND WIPES CLOTH
QUEST USA CORP
_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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BIOPURE ANTIBACTERIAL HAND WIPES
ACTIVE INGREDIENT(S)
Ethyl Alcohol 75% v/v
PURPOS E
Antibacterial
US E
For Hand Sanitizer to decrease bacterial on the skin
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 and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
peel the sticker when you use it.
Easily get one wipe at a time.
After application, please re-seal the opening sticker firmly to
prevent wipes from drying out
OTHER INFORMATION
Store between 0-40C (32-104F)
Avoid freezing and excessive heat above 40C (104F)
INACTIVE INGREDIENTS
pure water
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL
100 wipes in 1 bag. NDC: 78691-001-01;
ANTIBACTERIAL HAND WIPES
biopure antibacterial hand wipes cloth
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:78 6 9 1-0 18
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
0 .75 U in 1 U
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)
0 .0 0 1 U in 1 U
WATER (UNII: 0 59 QF0 KO0 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:78 6 9 1-0 18 -0 2 10 0 U in 1 CANISTER; Type 0 : No t a Co
mbinatio n Pro duct
0 7/0 1/20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START