Dr. Hess Hand Sanitizer by Dr. Hess Wellness Corp. / Fresh & Beautiful Cosmetics Drug Facts

Dr. Hess Hand Sanitizer by

Drug Labeling and Warnings

Dr. Hess Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Dr. Hess Wellness Corp., Fresh & Beautiful Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. HESS HAND SANITIZER- alcohol gel 
Dr. Hess Wellness Corp.

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Drug Facts

Active Ingredients

Ethyl Alcohol 70%.

Purpose

Antibacterial

Use

For rinse-free hand sanitizing to remove 99.9% bacteria on skin.

Warnings

Flammable. Keep away from fire or flame. For external use only.

When using this product

Do not use in eyes. In case of contact with eyes, rinse with water.

Stop use and ask a doctor if

irritation and redness develop and persist.

Keep out of reach of children.

If swallowed, get medical help promptly.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other Information

Store under 105°F

Inactive Ingredients

Water, Acrylates Copolymer, Aloe Barbadensis Leaf Juice, Glycerin, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

Principal Display Panel – Bottle Label

Kills
99.9%
of Germs

Dr. Hess
1893

Ashland, Ohio

Dr. Hess
Hand
Sanitizer

70% Alcohol

Anti-Bacterial Hand Gel

8 fl oz (236 ml)

DR. HESS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79346-101
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
Water (UNII: 059QF0KO0R)
Butyl Acrylate/Methyl Methacrylate/Methacrylic Acid Copolymer (18000 MW) (UNII: JZ1374NL9E)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Glycerin (UNII: PDC6A3C0OX)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Aminomethylpropanol (UNII: LU49E6626Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79346-101-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/31/2020
2	NDC: 79346-101-02	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/31/2020
3	NDC: 79346-101-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/31/2020
4	NDC: 79346-101-04	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/31/2020
5	NDC: 79346-101-07	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	12/14/2024
6	NDC: 79346-101-08	4 in 1 BOX	07/01/2020	12/14/2024
6		3785 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	07/01/2020	12/14/2024

Labeler - Dr. Hess Wellness Corp. (117544756)

Establishment
Name	Address	ID/FEI	Business Operations
Fresh & Beautiful Cosmetics		117409349	MANUFACTURE(79346-101)

Revised: 10/2023

Document Id: 06684ecc-fa98-4f75-a590-f9a31161f49b

34390-5

Set id: 68b92454-54f4-4b26-9fba-7a642d0eb9fd

Version: 3

Effective Time: 20231018