HAND SANITIZER GEL, 70% ETHYL ALCOHOL, 72580-306

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Formology Lab Inc., Expackusa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER  70 PERCENT- ethyl alcohol gel 
Formology Lab Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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HAND SANITIZER GEL, 70% ETHYL ALCOHOL, 72580-306

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

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 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.

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

Water (Aqua), Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citrus Limon (Lemon) Peel Oil

QUESTIONS?

Call toll free-1-833-778-1690

HAND SANITIZER   70 PERCENT
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72580-306
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
LEMON OIL (UNII: I9GRO824LL)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72580-306-11	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
2	NDC: 72580-306-12	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
3	NDC: 72580-306-13	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2020
4	NDC: 72580-306-14	45 mL in 1 TUBE; Type 0: Not a Combination Product	06/28/2020
5	NDC: 72580-306-17	30 mL in 1 TUBE; Type 0: Not a Combination Product	06/28/2020
6	NDC: 72580-306-18	100 mL in 1 TUBE; Type 0: Not a Combination Product	06/28/2020
7	NDC: 72580-306-15	500 mL in 1 POUCH; Type 0: Not a Combination Product	06/28/2020
8	NDC: 72580-306-16	1.5 mL in 1 POUCH; Type 0: Not a Combination Product	06/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/28/2020

Labeler - Formology Lab Inc. (081102403)

Establishment
Name	Address	ID/FEI	Business Operations
Expackusa, Inc.		079234982	pack(72580-306)

Establishment
Name	Address	ID/FEI	Business Operations
Formology Lab Inc.		081102403	manufacture(72580-306)

Revised: 10/2021

Document Id: ceb7f964-c51c-2d74-e053-2995a90af00f

34390-5

Set id: cb972715-5b98-4756-ae31-2c2fc4b6cd10

Version: 2

Effective Time: 20211019