ASSURED INSTANT- ethyl alcohol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Greenbrier International, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses - for handwashing to decrease bacteria on the skin - recommended for repeated use Instant Hand Sanitizer Vitamin E and Aloe Kills 99% of Germs! 8 fl oz /237 mL

Authorization status:

OTC monograph not final

Summary of Product characteristics

ASSURED INSTANT- ETHYL ALCOHOL GEL
GREENBRIER INTERNATIONAL, 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._
----------
ASSURED INSTANT
_ACTIVE INGREDIENT PURPOSE_
Ethyl Alcohol 62.0% ............... Antimicrobial
_USES_
for handwashing to decrease bacteria on the skin
recommended for repeated use
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
Instant Hand Sanitizer
Vitamin E and Aloe
Kills 99% of Germs!
8 fl oz /237 mL
_DIRECTIONS_
wet hands thoroughly with product
briskly rub hands together until dry
supervise children under 6 years on the use of this product
_WARNINGS_
FOR EXTERNAL USE ONLY.
FLAMMABLE, KEEP AWAY FROM HEAT AND FLAME.
DO NOT USE in the eyes. In case of contact, rinse eyes thoroughly with
water.
STOP USE AND ASK A DOCTOR IF irritation and redness develop and
persist for more than 72 hours.
_INACTIVE INGREDIENTS_ water, carbomer, triethanolamine, glycerin,
propylene glycol, fragrance, aloe
barbadensis leaf juice, tocopheryl acetate.
ASSURED INSTANT
ethyl alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:339 9 2-30 14
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
6 2 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
Greenbrier International, Inc.
CARBO MER CO PO LYMER TYPE A (UNII: 71DD5V9 9 5L)
TRO LAMINE (UNII: 9 O3K9 3S3TK)
GLYCERIN (UNII: PDC6 A3C0 OX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:339 9 2-30 14-1 237 mL in 1 PACKAGE; Type 0 : No t a Co mbinatio n
Pro duct
0 6 /0 3/20 15
M