High Five by Jani-Source, LLC / ABC Compounding Co., Inc. HIGH FIVE- alcohol gel

High Five by

Drug Labeling and Warnings

High Five by is a Otc medication manufactured, distributed, or labeled by Jani-Source, LLC, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

High Five 6605 800ml

6605M4P10027.jpg   High Five  800ml 

INGREDIENTS AND APPEARANCE

HIGH FIVE  
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49557-221
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49557-221-06	1 in 1 BOX
1		800 mL in 1 BAG
2	NDC: 49557-221-17	532 mL in 1 BOTTLE, PLASTIC
3	NDC: 49557-221-24	118 mL in 1 BOTTLE, PLASTIC
4	NDC: 49557-221-01	1200 mL in 1 CARTRIDGE
5	NDC: 49557-221-03	350 mL in 1 CARTRIDGE
6	NDC: 49557-221-05	540 mL in 1 BOTTLE, PLASTIC
7	NDC: 49557-221-07	700 mL in 1 BAG
8	NDC: 49557-221-09	2000 mL in 1 CARTRIDGE
9	NDC: 49557-221-10	1000 mL in 1 CARTRIDGE
10	NDC: 49557-221-11	1000 mL in 1 BOTTLE, PLASTIC
11	NDC: 49557-221-12	1000 mL in 1 BAG
12	NDC: 49557-221-13	800 mL in 1 BAG
13	NDC: 49557-221-14	3785 mL in 1 BOTTLE, PLASTIC
14	NDC: 49557-221-15	946 mL in 1 BOTTLE, PLASTIC
15	NDC: 49557-221-28	149 mL in 1 BOTTLE, PLASTIC
16	NDC: 49557-221-27	800 mL in 1 CARTRIDGE
17	NDC: 49557-221-55	208200 mL in 1 DRUM
18	NDC: 49557-221-08	1 in 1 BOX
18		1000 mL in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/01/2013

Labeler - Jani-Source, LLC (079224675)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(49557-221)