Antibacterial Cucumber Melon Foaming Hand Soap

Alpha by

Drug Labeling and Warnings

Alpha by is a Otc medication manufactured, distributed, or labeled by Alpha Aromatics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALPHA- antibacterial cucumber melon foaming hand soap spray 
Alpha Aromatics

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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Antibacterial Cucumber Melon Foaming Hand Soap

Active Ingredient

Benzalkonium Chloride 0.15% (w/w)

Purpose

Antibacterial

Use

Handwash to help decrease bacteria on the skin

Warnings

For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician

Stop use if, in rare instances, redness or irritation develops, If condition persists for more than 72 hours, consult a physician

Keep out of reach of children. If swallowed, contact a physician or poison control center

Directions

To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse

Inactive Ingredients

water, sorbitol, glycerine, decyl glucoside, dmdm hydantoin, fragrance

Package Label - Principal Display Panel

3.78L NDC: 75009-203-01

18.933L NDC: 75009-203-02

208.269L NDC: 75009-203-03

1041.556L NDC: 75009-203-04

ALPHA 
antibacterial cucumber melon foaming hand soap spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75009-203
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75009-203-01	3787 g in 1 JUG; Type 0: Not a Combination Product	02/17/2022
2	NDC: 75009-203-02	18933 g in 1 PAIL; Type 0: Not a Combination Product	02/17/2022
3	NDC: 75009-203-03	208269 g in 1 DRUM; Type 0: Not a Combination Product	02/17/2022
4	NDC: 75009-203-04	1041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	02/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/17/2022	09/01/2023

Labeler - Alpha Aromatics (041723545)

Establishment
Name	Address	ID/FEI	Business Operations
Alpha Aromatics		041723545	manufacture(75009-203)

Revised: 9/2023

Document Id: 06809e92-1a62-b814-e063-6394a90a1978

34390-5

Set id: d8384af0-3409-44bd-e053-2a95a90aa347

Version: 2

Effective Time: 20230929