ALCO SAN- alcohol gel 
Mid American Research Chemical Corp

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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Alco San Instant Hand Sanitizer 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, DMDM hydantoin, tocopheryl acetate, aloe barbadensis

Alco San 6605 5oz

product label

Alco San 5oz

ALCO SAN 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64233-221
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER 934 (UNII: Z135WT9208)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIISOPROPYLAMINE (UNII: BR9JLI40NO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64233-221-061 in 1 BOX07/01/2015
1800 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:64233-221-17532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
3NDC:64233-221-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
4NDC:64233-221-011200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/01/2015
5NDC:64233-221-03350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/01/2015
6NDC:64233-221-05540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
7NDC:64233-221-07700 mL in 1 BAG; Type 0: Not a Combination Product07/01/2015
8NDC:64233-221-092000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/01/2015
9NDC:64233-221-101000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/01/2015
10NDC:64233-221-111000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
11NDC:64233-221-121000 mL in 1 BAG; Type 0: Not a Combination Product07/01/2015
12NDC:64233-221-13800 mL in 1 BAG; Type 0: Not a Combination Product07/01/2015
13NDC:64233-221-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
14NDC:64233-221-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
15NDC:64233-221-28149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2015
16NDC:64233-221-27800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product07/01/2015
17NDC:64233-221-55208200 mL in 1 DRUM; Type 0: Not a Combination Product07/01/2015
18NDC:64233-221-081 in 1 BOX07/01/2015
181000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/01/2015
Labeler - Mid American Research Chemical Corp (051254092)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(64233-221)

Revised: 1/2019
Document Id: 61966a58-1550-4227-956b-b1f0c63d3ccf
Set id: 56462f92-34b7-4c3c-b08a-41e77711cdb4
Version: 2
Effective Time: 20190102
 
Mid American Research Chemical Corp