ANTIOCHPHARMA HAND SANITIZER- alcohol gel

AntiochPharma Hand Sanitizer by

Drug Labeling and Warnings

AntiochPharma Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Weeks & Leo, Weeks & Leo Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Alcohol 70% v/v..................................................................Antiseptic

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

Do not use

in children less than 2 months of ageon 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 15–30 °C (59–86 °F)

Avoid freezing and excessive heat above 40 °C (104 °F)

Close cap after use

May discolor certain fabrics or surfaces

Inactive Ingredients

acrylates/C10–30 alkyl acrylate crosspolymer, aminomethyl propanol, glycerin, isopropyl myristate, propylene glycol, purified water, SD alcohol 40-B, tocopheryl acetate

Package Label

AntiochPharma

Hand Sanitizer

With Vitamin E and Moisturizers

Kills 99.99 %of germs

made in USA

INGREDIENTS AND APPEARANCE

ANTIOCHPHARMA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11383-308
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
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11383-308-12	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
2	NDC: 11383-308-34	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020
3	NDC: 11383-308-09	259 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/24/2020

Labeler - Weeks & Leo (005290028)

Registrant - Weeks & Leo Co., Inc. (005290028)

Establishment
Name	Address	ID/FEI	Business Operations
Weeks & Leo Co., Inc.		005290028	manufacture(11383-308)