FIRST AID ANTISEPTIC- isopropyl alcohol liquid

First Aid Antiseptic by

Drug Labeling and Warnings

First Aid Antiseptic by is a Otc medication manufactured, distributed, or labeled by REALCHEM MANUFACTURING, RealChem Manufacturing Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a first aid antiseptic manufactured according to FDA Guidance.

Active Ingredient(s)

Isopropyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Antiseptic to decrease germs in minor cuts and scrapes and for preparation of skin prior to an injection; 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 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.

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

• Clean the affected area; apply small amount of product on the area 1 to 3 times daily.
• 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

purified water USP

Package Label - Principal Display Panel

473 ml NDC: 79363-710-16

946 ml NDC: 79363-710-32

237ml NDC: 79363-710-08

3785ml NDC: 79363-710-28

INGREDIENTS AND APPEARANCE

FIRST AID ANTISEPTIC 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79363-710
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79363-710-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020
2	NDC: 79363-710-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020
3	NDC: 79363-710-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020
4	NDC: 79363-710-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/17/2020

Labeler - REALCHEM MANUFACTURING (120491681)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117584702	manufacture(79363-710) , pack(79363-710) , repack(79363-710)

Establishment
Name	Address	ID/FEI	Business Operations
RealChem Manufacturing Inc		117742005	manufacture(79363-710) , pack(79363-710) , repack(79363-710)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117828480	manufacture(79363-710) , pack(79363-710) , repack(79363-710)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		120491681	manufacture(79363-710) , pack(79363-710) , repack(79363-710)