HAND SANITIZER- alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by REALCHEM MANUFACTURING. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer unscented gel manufactured according to FDA Guidance.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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 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

• 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

glycerin, RapidGel EZ1, purified water USP

Package Label - Principal Display Panel

118 ml NDC: 79363-701-04

237 ml NDC: 79363-701-08

473 ml NDC: 79363-701-16

946 ml NDC: 79363-701-32

3785 mL NDC: 79363-701-28

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79363-701
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
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79363-701-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 79363-701-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
3	NDC: 79363-701-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
4	NDC: 79363-701-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
5	NDC: 79363-701-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - REALCHEM MANUFACTURING (120491681)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117584702	manufacture(79363-701) , pack(79363-701) , repack(79363-701)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117742005	manufacture(79363-701) , pack(79363-701) , repack(79363-701)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117828480	manufacture(79363-701) , pack(79363-701) , repack(79363-701)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		120491681	manufacture(79363-701) , pack(79363-701) , repack(79363-701)