Expackusa HAND SANITIZER GEL, 70% ALCOHOL (77413-102) - DELIST

HAND SANITIZER by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER 70 PERCENT- ethyl alcohol gel 
Expackusa, 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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Expackusa HAND SANITIZER GEL, 70% ALCOHOL (77413-102) - DELIST

ACTIVE INGREDIENT

ETHYL ALCOHOL 70% V/V

PURPOSE

ANTISEPTIC

USES

TO DECREASE BACTERIA ON THE SKIN THAT POTENTIALLY CAN CAUSE DISEASE

WARNINGS

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE IN THE EYES.

STOP USE AND ASK A DOCTOR IF IRRITATION OR PAIN OCCURS.

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY A SUFFICIENT AMOUNT OF PRODUCT TO YOUR PALM TO COVER BOTH HANDS.
• RUB UNTIL DRY.

OTHER INFORMATION

• STORE BELOW 110F (43C)

INACTIVE INGREDIENTS

AQUA, ALOE BARBADENSIS LEAF JUICE, GLYCERIN, HYDROXYETHYLCELLULOSE, CITRUS LIMON PEEL OIL

HAND SANITIZER  70 PERCENT
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77413-102
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
LEMON OIL (UNII: I9GRO824LL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77413-102-03	3 mL in 1 POUCH; Type 0: Not a Combination Product	08/25/2020	12/31/2020
2	NDC: 77413-102-01	1.5 mL in 1 POUCH; Type 0: Not a Combination Product	08/25/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/25/2020	12/31/2020

Labeler - Expackusa, Inc. (079234982)

Revised: 6/2023

Document Id: fecdecf4-0b08-e19c-e053-6394a90a9dce

34390-5

Set id: 9f70fd3e-e533-4d2d-8875-d6659147dcff

Version: 7

Effective Time: 20230623