HAND SANITIZER GEL W/VIT E/ALOE- alcohol gel

Hand Sanitizer Gel w/Vit E/Aloe by

Drug Labeling and Warnings

Hand Sanitizer Gel w/Vit E/Aloe 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 containing Vitamin E and Aloe 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 EZ-1, Tocopheryl Acetate (Vitamin E), Aloe Barbedensis (Pure Inner Leaf Juice), purified water USP

Package Label - Principal Display Panel

237 mL NDC: 79363-704-08

473 ml NDC 79363-704-16

3789ml 79363-704-28

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL W/VIT E/ALOE 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79363-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	2.154 g  in 100 g
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.033 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.014 g  in 100 g
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)	1.048 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79363-704-16	412 g in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2020
2	NDC: 79363-704-08	206 g in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2020
3	NDC: 79363-704-28	3296 g in 1 BOTTLE; Type 0: Not a Combination Product	08/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/31/2020

Labeler - REALCHEM MANUFACTURING (120491681)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117584702	manufacture(79363-704) , pack(79363-704) , repack(79363-704)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117742005	manufacture(79363-704) , pack(79363-704) , repack(79363-704)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		117828480	pack(79363-704) , manufacture(79363-704) , repack(79363-704)

Establishment
Name	Address	ID/FEI	Business Operations
REALCHEM MANUFACTURING		120491681	manufacture(79363-704) , pack(79363-704) , repack(79363-704)