OPE ELITE BRANDS SUPERIOR HAND SANITIZER

OPE ELITE BRANDS HAND SANITIZER by

Drug Labeling and Warnings

OPE ELITE BRANDS HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by Ope Elite Brands Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OPE ELITE BRANDS HAND SANITIZER- alcohol gel 
Ope Elite Brands Llc

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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OPE ELITE BRANDS SUPERIOR HAND SANITIZER

DRUG FACTS

ACTIVE INGREDIENTS

Ethyl Alcohol 70% V / V

PURPOSE

Antiseptic

USES:

For handwashing to decrease bacteria on the skin.

WARNINGS:

Flammable. For external use only Do not use in eyes, In case of contact rinse thoroughly with water. Stop use and ask a Doctor if irritation or rash appears and lasts

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS:

Wet hands thoroughly with product briskly rub hands together until dry supervise children under 6 years in the use of this product

INACTIVE INGREDIENTS

Water, Glycerin, acrylates/c10-30 alkyl acrylate cross polymer, aminomethyl propanol, isopropyl alcohol, isopropyl myristate, caprylyl glycol, phenoxyethanol, benzophenone-4, tocopheryl acetate

SUPERIOR HAND SANITIZER

KILLS 99.99% OF GERMS

MAXIMUM STRENGTH

ETHYL ALCOHOL 70%

CONTAINS MOISTURIZER LEAVES HANDS SOFT

DISTRIBUTED BY:

OPE ELITE BRANDS

HIALEAH FLORIDA, 33010

WWW.AHANDSANITIZER.COM

ENRICHED WITH VITAMIN E AND MOISTURIZER

OTHER INGREDIENTS

PROPANOL AND FRAGRANCE.

MADE IN DOMINICAN REPUBLIC

Packaging

OPE ELITE BRANDS HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79507-070
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)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SULISOBENZONE (UNII: 1W6L629B4K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79507-070-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
2	NDC: 79507-070-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
3	NDC: 79507-070-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
4	NDC: 79507-070-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
5	NDC: 79507-070-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
6	NDC: 79507-070-32	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023
7	NDC: 79507-070-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2020	02/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020	02/28/2023

Labeler - Ope Elite Brands Llc (117574380)

Revised: 10/2021

Document Id: d8e13771-2655-4348-9d58-7bd8a22c3c7c

34390-5

Set id: cd1f044e-68e3-4f21-ad3a-07f4c4b052b0

Version: 2

Effective Time: 20211004