ANTIBACTERIAL MODESS BASICS- benzalkonium chloride 0.13% cream 
CLICK PRODUCTS 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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Antibacterial Skin Cream with Aloe Vera, Allantoin and Vitamins A,D & E

Benzalkonium Chloride - 0.13%

Purpose - Antibacterial

-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 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

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

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ANTIBACTERIAL  MODESS BASICS
benzalkonium chloride 0.13% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71611-079-14141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/22/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/22/2021
Labeler - CLICK PRODUCTS LLC (080766174)
Registrant - CLICK PRODUCTS LLC (080766174)
Establishment
NameAddressID/FEIBusiness Operations
Brands International Corporation243748238manufacture(71611-079)

Revised: 7/2021
Document Id: c7c1d47f-6f7a-31cc-e053-2a95a90a1f80
Set id: c7c1d47f-6f79-31cc-e053-2a95a90a1f80
Version: 1
Effective Time: 20210722
 
CLICK PRODUCTS LLC