MARKET AMERICA HAND SANITIZER- alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Market America

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antiseptic For handwashing to decrease bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

MARKET AMERICA HAND SANITIZER- ALCOHOL GEL
MARKET AMERICA
_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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Ethyl Alcohol 63.00%
PURPOS E
Antiseptic
KEEP OUT OF REACH OF CHILDREN
If swallowed get medical help or contact a Poison Control Center right
away.
US ES
For handwashing to decrease bacteria on the skin.
WARNINGS
For external use only: Hands. Flammable. Keep away from fire or 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 irritation and
redness develop. Condition persists
for more than 72 hours.
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.
INACTIVE INGREDIENTS
Carbomer, DMDM Hydantoin, Fragrance, Isopropanol, Propylene Glycol,
Tocopheryl Acetate,
Triethanolamine, Water.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
MARKET AMERICA HAND SANITIZER
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 20 9 -16 6
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
Market America
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
58 .10 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
0 .0 10 mg in 1 g
CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED)
(UNII: 4Q9 3RCW27E)
.310 mg in 1 g
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
.50 0 mg in 1 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 20 9 -16 6 -0 3
1 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct
12/16 /20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICAT