PRO SAN- alcohol liquid 
Atco International

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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PRO SAN 6650 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 and 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, propylene glycol, acid blue 25, fragrance

PRO SAN 6650

product label

PRO SAN 6650

PRO SAN 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62712-665
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ACID BLUE 25 (UNII: S2E15W6FSN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62712-665-143785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
2NDC:62712-665-15946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
3NDC:62712-665-47473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
4NDC:62712-665-24118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/14/2020
Labeler - Atco International (033504929)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIBusiness Operations
ABC Compounding Co., Inc.003284353manufacture(62712-665)

Revised: 4/2020
Document Id: 126a486a-7307-46dc-914c-fde72d27897c
Set id: 0b5b4fca-43eb-4b39-9688-6a5d8b70b142
Version: 1
Effective Time: 20200414
 
Atco International