ALCOHOL ANTISEPTIC- alcohol solution 
Seaway Pharma 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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Ethylalcohol 70% Hand sanitizer solution

Active Ingredient(s)

Alcohol 70% v/v.............................. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

aloe vera gel, amino methyl propanol, carbomer, FD&C blue #1·, FD&C yellow #10·, fragrance, purified water, vitamin E
•may contain one or more of these ingredients if the product is a colored gel.

Package Label - Principal Display Panel

8 fl oz (237 mL) NDC: 73414-057-08

containerlabel8floz

16 fl oz (473 mL) NDC: 73414-057-13

containerlabel16floz

32 fl oz (946 mL) NDC: 73414-057-14

containerlabe32floz

1 Gallon (3.78 L) NDC: 73414-057-91

containerlabel1gal

ALCOHOL ANTISEPTIC 
alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73414-057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
GLYCERIN (UNII: PDC6A3C0OX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73414-057-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
2NDC:73414-057-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
3NDC:73414-057-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
4NDC:73414-057-08177 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
5NDC:73414-057-13473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
6NDC:73414-057-14946 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
7NDC:73414-057-913780 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2020
Labeler - Seaway Pharma Inc. (117218785)
Registrant - Seaway Pharma Inc. (117218785)
Establishment
NameAddressID/FEIBusiness Operations
Seaway Pharma Inc.117218785manufacture(73414-057)

Revised: 7/2020
Document Id: b4685e39-5924-4a0b-a29b-55a55de3e558
Set id: d3d8f36e-8e7f-4e18-a405-af49034656b8
Version: 1
Effective Time: 20200726
 
Seaway Pharma Inc.