FOAM 103- antibacterial foaming soap soap

foam 103 by

Drug Labeling and Warnings

foam 103 by is a Otc medication manufactured, distributed, or labeled by Alpha Aromatics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.15%(w/w)

Purpose

Anitbacterial

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

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

KEEP OUT OF REACH OF CHILDREN

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

3.78 L NDC: 75009-103-01

18.92 L NDC: 75009-103-02

208.19 L NDC: 75009-103-03

1040.98 L NDC: 75009-103-04

INGREDIENTS AND APPEARANCE

FOAM 103 
antibacterial foaming soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75009-103
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
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
DIHYDROMYRCENOL (UNII: 46L1B02ND9)
HEXYL ACETATE (UNII: 7U7KU3MWT0)
WATER (UNII: 059QF0KO0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)	1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75009-103-01	3787 g in 1 JUG; Type 0: Not a Combination Product	05/25/2020
2	NDC: 75009-103-02	18933 g in 1 PAIL; Type 0: Not a Combination Product	05/25/2020
3	NDC: 75009-103-03	208269 g in 1 DRUM; Type 0: Not a Combination Product	05/25/2020
4	NDC: 75009-103-04	1041556 g in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	05/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/25/2020

Labeler - Alpha Aromatics (041723545)

Establishment
Name	Address	ID/FEI	Business Operations
Alpha Aromatics		041723545	manufacture(75009-103)