CORETEX ANTIBACTERIAL HAND SANITIZER- sd alcohol liquid

CoreTex Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

CoreTex Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by CoreTex Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Uses:

Hand Sanitizer to help reduce bacteria on the skin.

Warnings:

For external use only.

Flammable. Do not use near heat, flame or while smoking.

When using this product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor

if irritation or rash appears and lasts.

Keep out of reach of children.

If swallowed, get help or contact a Poison Control Center right away.

Directions:

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Inactive Ingredients:

aloe barbadenis leaf juice(aloe vera), amino methylpropanol, carbomer, glycerin, isopropyl myristate, tocopherol acetate (vitamin E acetate), water

Other Information:

Store below 104 oF (40 oC), Read the Safety Data Sheet for this Product. You may obtain an SDS from our website: www.coretexproducts.com

Questions and comments:

Please call: 1-877-684-5774 or email us at Skincare@coretexproducts.com

SPL UNCLASSIFIED SECTION

Made in USA for CoreTex Products, Inc.

Erwin, TN 37650 |www.CoreTexProducts.com | (877) 684-5774

65753-201-01

65753-201-02

65753-201-03

65753-201-05

65753-201-06

65753-201-07

65753-201-10

65753-201-28

65753-201-29

65753-201-30

65753-201-32

65753-201-20 and -21

65753-201-35

INGREDIENTS AND APPEARANCE

CORETEX ANTIBACTERIAL HAND SANITIZER 
sd alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65753-201
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
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65753-201-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
2	NDC: 65753-201-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
3	NDC: 65753-201-03	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
4	NDC: 65753-201-32	44 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
5	NDC: 65753-201-28	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024
6	NDC: 65753-201-05	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
7	NDC: 65753-201-29	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024
8	NDC: 65753-201-06	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
9	NDC: 65753-201-07	354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024
10	NDC: 65753-201-30	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2024
11	NDC: 65753-201-10	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024
12	NDC: 65753-201-20	25 in 1 CONTAINER	01/01/2024
12		3.5 mL in 1 POUCH; Type 0: Not a Combination Product
13	NDC: 65753-201-21	300 in 1 CONTAINER	01/01/2024
13		3.5 mL in 1 POUCH; Type 0: Not a Combination Product
14	NDC: 65753-201-35	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/01/2024

Labeler - CoreTex Products Inc (061944620)

Establishment
Name	Address	ID/FEI	Business Operations
CoreTex Products Inc		061944620	pack(65753-201) , label(65753-201)