Sky Organics Hand Sanitizer by Natural Essentials, Inc. / NATURAL ESSENTIALS, INC. Drug Facts

Sky Organics Hand Sanitizer by

Drug Labeling and Warnings

Sky Organics Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Natural Essentials, Inc., NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SKY ORGANICS HAND SANITIZER- alcohol gel 
Natural Essentials, Inc.

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Drug Facts

Active ingredient

Ethyl Alcohol 70%

Purpose

Antibacterial

Uses

• Hand sanitizer to help decrease bacteria on the skin.

Warnings

Flammable, keep away from fire, sparks, and sources of ignition.

For external use only.

When using this productDo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin.

Stop use and ask doctor ifirritation or redness develops and persists.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Put enough product in your palm to cover hands and rub hands together promptly until dry. Adult supervision required during application to children.

Not recommended for infants.

Other information

• Do not store above 105°F (41 °C).

Inactive ingredients

Acrylates/Vinyl Isodecanoate Crosspolymer, Aloe barbadensis (Aloe vera) leaf, PEG-6, PEG-12 Dimethicone, Water (Aqua). *Not an organic product

Sky Organics, 429 Lenox Ave, Suite 435 Miami Beach, FL 33139 ■ Contact: help@skyorganics.com, 1-(888) 899-9305 FDA# 20590. Made in USA.

Principal Display Panel – 16 FL OZ Bottle Label

sky organics*

UNSCENTED

Hand
Sanitizer Gel
with moisturizing aloe vera

kills 99.9% of germs

90% natural ingredients

crueltyfree

Made in USA

16 FL OZ e 473 ML

SKY ORGANICS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-843-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2020	10/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	09/15/2020	10/08/2024

Labeler - Natural Essentials, Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-843)

Revised: 10/2024

Document Id: 23f98760-1695-df84-e063-6394a90acd9e

34390-5

Set id: 9705b90e-26b2-4e51-88d2-30400a53d4f4

Version: 2

Effective Time: 20241008