HAND SANITIZER- ethyl alcohol gel

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Charles and Associates, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation):

1. Alcohol (71%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (0.5% v/v).
3. Carbomer (8.0% v/v).
4. Trolamine (1.0% v/v).
5. Sterile distilled water or boiled cold water.

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria on the skin that potentially can cause sickness, recommended for repeated use.

Warnings

For external use only. Flammable. Keep away from heat and flame.

WHEN USING

Avoid contact with eyes, ears, and mouth. If contact does occur, flush with water.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

STOP USE

Stop use and ask a doctor if irritation and redness develop and presists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help, or contact poison control center right away.

Directions

• Apply a small amount to palms, rubbing briskly to cover both hands until dry - repeat as necessary.
• Supervise children under 6 years with the use of this product. Do not use on infants.

Other information

• Store at room temperature
• May discolor certain fabrics
• Harmful to wood finishes and plastics

Inactive ingredients

Deminerialized water, Carbopol 960, Triethanolamine, Glycerin

Package Label - Principal Display Panel

1 gallon / 128 fl oz (3.79 liters) NDC: 78336-070-37

16.9 fl oz (500 ml) NDC: 78336-070-16

8.45 fl oz (250 ml) NDC: 78336-070-08

4.06 fl oz (120 ml) NDC: 78336-070-04

2.03 fl oz (60 ml) NDC: 78336-070-02

1 fl oz (30 ml) NDC: 78336-070-01

1 liter (1000ml) 33.8 fl oz NDC: 78336-070-10

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78336-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	19.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78336-170-37	3785 mL in 1 JUG; Type 0: Not a Combination Product	07/01/2020
2	NDC: 78336-170-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
3	NDC: 78336-170-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
4	NDC: 78336-170-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
5	NDC: 78336-170-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2020
6	NDC: 78336-170-01	30 mL in 1 BOTTLE, PLASTIC; 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

HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78336-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	71 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL  in 100 mL
CARBOMER 940 (UNII: 4Q93RCW27E)	8 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	19.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78336-070-37	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/12/2020
2	NDC: 78336-070-16	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020
3	NDC: 78336-070-08	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020
4	NDC: 78336-070-04	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020
5	NDC: 78336-070-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/12/2020
6	NDC: 78336-070-01	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/30/2020
7	NDC: 78336-070-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020

Labeler - Charles and Associates, LLC (120983354)