ALPHA- antibacterial cucumber melon foaming hand soap spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

Available from:

Alpha Aromatics

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial Handwash to help decrease bacteria on the skin Stop use if, in rare instances, redness or irritation develops, If condition persists for more than 72 hours, consult a physician

Authorization status:

OTC monograph not final

Summary of Product characteristics

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._
----------
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)
BENZ ALKONIUM
CHLORIDE
0.15 g
in 100 g
Alpha Aromatics
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: N