ANTIBACTERIAL MODESS BASICS- benzalkonium chloride 0.13% cream

Antibacterial by

Drug Labeling and Warnings

Antibacterial by is a Otc medication manufactured, distributed, or labeled by CLICK PRODUCTS LLC, Brands International Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride - 0.13%

PURPOSE

Purpose - Antibacterial

INDICATIONS & USAGE

-to relieve irritated and dry skin

-helps soothe and protect skin tissue

-helps reduce common germs that can cause painful rashes

-use as a massage cream for immobile patients to help improve circulation

Warnings For external use only

Avoid contact with eyes, if contact occurs, rinse eyes thoroughly with water

STOP USE

Stop use and ask a doctor if irritation or redness develops

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

When using this product

Avoid contact with eyes.In case of contact, flush and rinse with water.

Remove contact lenses, if present and easy to do. Continue rinsing.

Keep out of reach of children

Except under adult supervision. DO NOT EAT DRINK.

Keep away from food,drink and animal feeding stuffs,

If swallowed get medical help or contact posion control right away.

Directions

apply small amount to skin and rub in gently, apply as needed

INACTIVE INGREDIENT

Water, cetearyl alcohol, stearic acid, glyceryl stearate, PEG-40 hydrogenated castor oil, mineral oil, glycerin, carbomer, sodium hydroxide, aloe vera leaf extract, tocopheryl acetate, Vitamin A, Vitamin D, allantoin, DMDM hydantoin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL  MODESS BASICS
benzalkonium chloride 0.13% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71611-079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITAMIN A (UNII: 81G40H8B0T)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71611-079-14	141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/22/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	07/22/2021

Labeler - CLICK PRODUCTS LLC (080766174)

Registrant - CLICK PRODUCTS LLC (080766174)

Establishment
Name	Address	ID/FEI	Business Operations
Brands International Corporation		243748238	manufacture(71611-079)