HAND SANITIZER- ethyl alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sam's West Inc

INN (International Name):

ALCOHOL

Composition:

ALCOHOL 578 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic - to decrease bacteria on the skin that could cause disease - recommended for repeated use skin irritation develops.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER- ETHYL ALCOHOL GEL
SAM'S WEST INC
_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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ORIGINAL HAND SANITIZER
951.001/951AA/AB
ACTIVE INGREDIENT
Ethyl Alcohol 65%
PURPOSE
Antiseptic
USE
to decrease bacteria on the skin that could cause disease
recommended for repeated use
WARNINGS
FOR EXTERNAL USE ONLY-HANDS
FLAMMABLE. KEEP AWAY FROM HEAT AND FLAME.
WHEN USING THIS PRODUCT
keep out of eyes. In case of contact with eyes, flush thoroughly with
water
avoid contact with broken skin
do not inhale or ingest
STOP USE AND ASK A DOCTOR IF
skin irritation develops.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
wet hands thoroughly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants
OTHER INFORMATION
do not store above 105⁰ F
may discolor some fabrics
harmful to wood finishes and plastics
INACTIVE INGREDIENTS
benzophenone-4, carbomer, fragrance, glycerin, isopropyl myristate,
propylene glycol,
tocopheryl acetate, water
*Effective at eliminating 99.99% of many common harmful germs and
bacteria in as little
as 15 seconds
Distributed by SAM'S West, Inc.
608 S.W. 8th Street
Bentonville, AR 72716
This product not packaged for resale
PRINCIPAL DISPLAY PANEL
Member's Mark Quality Guaranteed
Hand Sanitizer
Kills 99.99% of germs*
Plus Moisturizers and Vitamin E
2 FL OZ (59 mL)
HAND SANITIZER
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:68196-951
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
578 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SULISOBENZONE (UNII: 1W6L629B4K)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CRO