HIGH FIVE  - alcohol gel 
Jani-Source, 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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High Five 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

High Five 6605 800ml

6605M4P10027.jpg   High Five  800ml  image of label

HIGH FIVE  
alcohol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49557-221
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CARBOMER 934 
PROPYLENE GLYCOL 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE, DL- 
DIISOPROPYLAMINE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49557-221-061 in 1 BOX
1800 mL in 1 BAG
2NDC:49557-221-17532 mL in 1 BOTTLE, PLASTIC
3NDC:49557-221-24118 mL in 1 BOTTLE, PLASTIC
4NDC:49557-221-011200 mL in 1 CARTRIDGE
5NDC:49557-221-03350 mL in 1 CARTRIDGE
6NDC:49557-221-05540 mL in 1 BOTTLE, PLASTIC
7NDC:49557-221-07700 mL in 1 BAG
8NDC:49557-221-092000 mL in 1 CARTRIDGE
9NDC:49557-221-101000 mL in 1 CARTRIDGE
10NDC:49557-221-111000 mL in 1 BOTTLE, PLASTIC
11NDC:49557-221-121000 mL in 1 BAG
12NDC:49557-221-13800 mL in 1 BAG
13NDC:49557-221-143785 mL in 1 BOTTLE, PLASTIC
14NDC:49557-221-15946 mL in 1 BOTTLE, PLASTIC
15NDC:49557-221-28149 mL in 1 BOTTLE, PLASTIC
16NDC:49557-221-27800 mL in 1 CARTRIDGE
17NDC:49557-221-55208200 mL in 1 DRUM
18NDC:49557-221-081 in 1 BOX
181000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E08/01/2013
Labeler - Jani-Source, Inc. (784889909)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(49557-221)

Revised: 8/2013
Document Id: 88296c08-2c82-4cba-bb48-d1b9e262360c
Set id: 72c9bb48-e947-45fd-a2aa-e16a3af7f9f7
Version: 1
Effective Time: 20130801
 
Jani-Source, Inc.