BIOPURE ANTIBACTERIAL HAND WIPES- alcohol cloth

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

QUEST USA CORP.

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

OTC DRUG

Θεραπευτικές ενδείξεις:

- Hand sanitizer to help reduce bacteria. - For use when soap and water are not available.

Καθεστώς αδειοδότησης:

OTC monograph not final

Αρχείο Π.Χ.Π.

BIOPURE ANTIBACTERIAL HAND WIPES- ALCOHOL 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._
----------
BIOPURE ANTIBACTERIAL HAND WIPES
_DRUG FACTS_
_ACTIVE INGREDIENT_
Ethyl Alcohol 75%
_PURPOSE_
Antibacterial
_USES_
Hand sanitizer to help reduce bacteria.
For use when soap and water are not available.
_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 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_
Apply to hands, allow to air dry without wiping.
Children under 6 years of age should be supervised when using this
product.
_OTHER INFORMATION_
Store in a cool, dry place, between 15°-30°C (59°F-86°F).
Avoid freezing and excessive heat above 40°C (104°F).
_INACTIVE INGREDIENT_
Purified water USP
_QUESTIONS?_
call 718-975-2586
PACKAGE LABELING:
BIOPURE ANTIBACTERIAL HAND WIPES
alcohol cloth
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:78691-016
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.75 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
QUEST USA CORP.
PACKAGING
#
ITEM
CODE
PACKAGE DESCRIPTION
MARKETING
START DATE
MARKETING
END DATE
1
NDC:78691-
016-01
100 in 1 CANISTER
11/15/2020
12/31/2022
1
5.4 mL in 1 PATCH; Type 2: Prefilled Drug Delivery
Device/System (syringe, patch, etc.)
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MAR