ALCOHOL ANTISEPTIC- alcohol gel

Alcohol Antiseptic by

Drug Labeling and Warnings

Alcohol Antiseptic by is a Otc medication manufactured, distributed, or labeled by Seaway Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

WHEN USING

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

STOP USE

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

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

Directions

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

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

2 fl oz (59 mL) NDC: 73414-058-01

8 fl oz (237 mL) NDC: 73414-058-08

16 fl oz (473 mL) NDC: 73414-058-13

32 fl oz (946 mL) NDC: 73414-058-14

1 Gallon (3.78 L) NDC: 73414-058-91

INGREDIENTS AND APPEARANCE

ALCOHOL ANTISEPTIC 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73414-058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER 1342 (UNII: 809Y72KV36)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73414-058-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 73414-058-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 73414-058-06	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
4	NDC: 73414-058-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
5	NDC: 73414-058-13	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
6	NDC: 73414-058-14	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020
7	NDC: 73414-058-91	3780 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Seaway Pharma Inc. (117218785)

Registrant - Seaway Pharma Inc. (117218785)

Establishment
Name	Address	ID/FEI	Business Operations
Seaway Pharma Inc.		117218785	manufacture(73414-058)