First Aid Antiseptic: Package Insert and Label Information

FIRST AID ANTISEPTIC- isopropyl alcohol liquid
REALCHEM MANUFACTURING

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.

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 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 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

• 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

FIRST AID ANTISEPTIC isopropyl alcohol liquid

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

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

Inactive Ingredients Ingredient Name Strength WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:79363-710-16 473 mL in 1 BOTTLE None 2 NDC:79363-710-32 946 mL in 1 BOTTLE None 3 NDC:79363-710-08 237 mL in 1 BOTTLE None 4 NDC:79363-710-28 3785 mL in 1 BOTTLE None

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	Operations
REALCHEM MANUFACTURING		117584702	manufacture (79363-710), pack (79363-710), repack (79363-710)

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

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

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

Revised: 02/2021 REALCHEM MANUFACTURING