HAND-E XL- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ABC Compounding Co., Inc.

INN (International Name):

ALCOHOL

Composition:

ALCOHOL 0.7 mL in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic for hand-washing to decrease bacteria on the skin, only when water is not available irritation and redness develop

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND-E XL- ALCOHOL GEL
ABC COMPOUNDING CO., 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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HAND-E XL 6605 DRUG FACTS AND LABEL
DRUG FACTS BOX OTC-ACTIVE INGREDIENT SECTION
Ethyl Alcohol 62%
DRUG FACTS BOX OTC-PURPOSE SECTION
Antiseptic
DRUG FACTS BOX OTC-INDICATIONS & USAGE SECTION
for hand-washing to decrease bacteria on the skin, only when water is
not available
DRUG FACTS BOX OTC-WARNINGS SECTION
FLAMMABLE, keep away from fire and flames
For external use only
DRUG FACTS BOX OTC-WHEN USING SECTION
do not get into eyes
if contact occurs, rinse eyes thoroughly with water
DRUG FACTS BOX OTC-STOP USE SECTION
irritation and redness develop
DRUG FACTS BOX OTC-KEEP OUT OF REACH OF CHILDREN SECTION
if swallowed, get medical help or contact a Poison Control Center
right away
DRUG FACTS BOX OTC-DOSAGE & ADMINISTRATION SECTION
wet hands thoroughly with product and allow to dry without wiping
DRUG FACTS BOX OTC-INACTIVE INGREDIENT SECTION
water, diisopropylamine, carbomer, propylene glycol, tocopheryl
acetate, aloe barbadensis
HAND-E XL 6605 DRUG FACTS AND LABEL
Hand-E XL 16 oz Label
HAND-E XL
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 2257-6 0 6
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 .7 mL in 1 mL
ABC Compounding Co., Inc.
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )
DIISO PRO PYLAMINE (UNII: BR9 JLI40 NO)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:6 2257-6 0 6 -
17
532 mL in 1