78691-200

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Quest USA Corp.

Indgivelsesvej:

TOPICAL

Recept type:

OTC DRUG

Terapeutiske indikationer:

Antiseptic ●Hand sanitizer to help reduce bacteria that potentially cause disease. ●For use when soap and water are not available. ●in children less than 2 months of age. ●on open skin wounds irritation or rash occurs. These may be signs of a serious condition.

Autorisation status:

OTC monograph not final

Produktets egenskaber

BIOPURE 50CT ANTIBACTERIAL HAND WIPES- 75% ETHYL ALCOHOL WET
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._
----------
78691-200
Ethyl Alcohol 75%
Antiseptic
USES
●Hand sanitizer to help reduce bacteria that potentially cause
disease.
●For use when soap and water are not available.
For external use only. Flammable. Keep away from heat or flame.
●in children less than 2 months of age.
●on open skin wounds
keep out of eyes, ears, and mouth. In case of contact with eyes, rinse
eyes thoroughly
with water.
irritation or rash occurs. These may be signs of a serious condition.
If swallowed. get medical help or contact a Poison Control Center
right away.
DIRECTIONS
●Apply to hands, allow to air dry without wiping.
●Discard wipe in trash receptacle after use.
● Do not flush.
OTHER INFORMATION
●Store in a cool, dry place, between 15°C-30°C 59°F-86°F
●Avoid freezing and excessive heat above 40°C 104°F
Aloe Barbadensis Extract, Alpha-Tocopherol, Glycerin, Purified Water
BIOPURE 50CT ANTIBACTERIAL HAND WIPES
75% ethyl alcohol wet wipes cloth
Quest USA Corp.
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78691-200
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
75 mL in 100 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:78691-200-
01
50 in 1 PAIL
01/12/2022
1
4 mL in 1 PATCH; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
OTC monograph not
final
part333E
0