DK12 LIQUID HAND OATMEAL- benzalkonium chloride 0.13% liquid 
Industria La Popular, S.A.

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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DK12 Liquid Hand Soap Oatmeal

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

For washing to decrease bacteria on the skin

Warnings

For External Use only.

When using this product

avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.


Stop use and ask a doctor

irritation or redness develops - condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse thoroughly.

Other Information

Store between 15-30C (59-86F)

Inactive Ingredients

Aqua, Sodium Lauryl Ether Sulfate, Sodium Chloride, Glycol Distearate/Laureth-4/Cocamidopropyl Betaine, Cocamide MEA, Glycerin, Phenoxyethanol, Fragrance, Methylchloroisothiazolinone/Methylisothiazolinone, Citric Acid

DK12 Liquid Hand Soap Oatmeal

labellabel

DK12 LIQUID HAND OATMEAL 
benzalkonium chloride 0.13% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 500 mL
Inactive Ingredients
Ingredient NameStrength
LAURETH-4 (UNII: 6HQ855798J)  
COCAMIDE (UNII: 3YXD33R71G)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62476-006-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2023
Labeler - Industria La Popular, S.A. (846044576)

Revised: 9/2023
Document Id: 05e4ca56-e0d5-8aa4-e063-6394a90a8055
Set id: 01e1c5f6-195c-16d6-e063-6394a90abb86
Version: 2
Effective Time: 20230921
 
Industria La Popular, S.A.