HAND-AID- 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.

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-AID- 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-AID 6605 DRUG FACTS AND LABEL
DRUG FACTS BOX OTC-ACTIVE INGREDIENT SECTION
Ethyl Alcohol 70% v/v
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, DMDM hydantoin, diidopropylamine, carbomer, propylene glycol,
tocopheryl
acetate, aloe barbadensis,
HAND-AID 6605 DRUG FACTS AND LABEL
6605M4PA_Hand-Aid
800ml bag 1-15-2021
HAND-AID
alcohol gel
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:62257-122
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
ALCOHOL
0.7 mL in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:62257-
122-17
532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a
Combination Produc