HN ESSENTIALS HAND SANITIZER GEL WITH ALOE VERA- alcohol solution

HN Essentials Hand Sanitizer Gel with Aloe Vera by

Drug Labeling and Warnings

HN Essentials Hand Sanitizer Gel with Aloe Vera by is a Otc medication manufactured, distributed, or labeled by Hue Noir, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Active ingredient: Ethyl Alcohol 62% (v/v)

Purpose

Purpose: Antimicrobial

Use

Use: to help reduce bacteria and germs on skin

Warnings:

Warnings:

For external use only

Flammable. Keep away from source of heat or fire.

WHEN USING

When using this product avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

STOP USE

Stop using and ask doctor if irritation or redness develops and persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of accidental ingestion, get medical help or contact poison control immediately.

Directions:

• Pour enough product on hands to conver all surfaces. Rub hands together until dry.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information:

Do not store above 104°F (40°C)

Inactive Ingredients:

Water (Aqua), Isopropyl Alcohol, Aloe Barbadensis, Glycerin, Polyacrylate crosspolymer-6 and/or Hydroxypropyl Methylcellulos (thickeners), Fragrance.

Package Label - Principal Display Panel NDC:

80920-855-04

HN Essentials

Hand Sanitizer Gel with Aloe Vera

62% Alcohol

Kills 99.9% of Germs*

4 fl oz/ 118 mL 

Package Label - Principal Display Panel NDC:

80920-855-08

HN Essentials

Hand Sanitizer Gel with Aloe Vera

62% Alcohol

Kills 99.9% of Germs*

8 fl oz/ 237 mL 

Package Label - Principal Display Panel NDC:

80920-855-16

HN Essentials

Hand Sanitizer Gel with Aloe Vera

62% Alcohol

Kills 99.9% of Germs*

16 fl oz/ 473 mL 

Package Label - Principal Display Panel NDC:

80920-855-10

HN Essentials

Hand Sanitizer Gel with Aloe Vera

62% Alcohol

Kills 99.9% of Germs*

1gal/ 3.8 mL 

INGREDIENTS AND APPEARANCE

HN ESSENTIALS HAND SANITIZER GEL WITH ALOE VERA 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80920-855
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	65 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	2 mL  in 100 mL
ALOE (UNII: V5VD430YW9)	2 mL  in 100 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302)	1 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.15 mL  in 100 mL
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)	.05 mL  in 100 mL
HYDROXYPROPYL CELLULOSE (110000 WAMW) (UNII: 5Y0974F5PW)	.40 mL  in 100 mL
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)	0.40 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80920-855-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2020
2	NDC: 80920-855-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2020
3	NDC: 80920-855-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2020
4	NDC: 80920-855-10	3800 mL in 1 JUG; Type 0: Not a Combination Product	11/13/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/13/2020

Labeler - Hue Noir, LLC (879554066)

Establishment
Name	Address	ID/FEI	Business Operations
Hue Noir, LLC		879554066	manufacture(80920-855)