1438 DYNASOAP- antibacterial hand soap soap 
Dynarex Corporation

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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1438 Dyna Soap - Antibacterial Hand Soap 67777-319-01

Active Ingredient

Benzalkonium Chloride 0.13%.......Antiseptic handwash

Purpose

Antibacterial Hand Soap

Use

Cleaning and antiseptic cleansing of hands and skin.

Warnings

For external use only.

When using this product

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

Stop use and ask a doctor if.

Irritation and redness develop.

Keep out of reach of children.

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

Directions.

Wet hands and forearms. Apply 5 millileters (teaspoon) or palmful to hands and forearms. Scrub thoroughly for 1 minute. Rinse and repeat.

Inactive Ingredients

Benzyl Alcohol, Citric Acid Monohydrate, Cocamide DEA, Cocamidopropyl Betaine, Glycerin, Lauryl Glucoside, Methylchloroisothiazolinone, Methylisothiazolinone, Parfum, Sodium Chloride, Sodium Laureth Sulfate, Sulisobenzone, Water.

Label

1438 DynaSoap Label1438 DynaSoap Label

1438 DYNASOAP 
antibacterial hand soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SULISOBENZONE (UNII: 1W6L629B4K)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-319-0124 in 1 CASE08/01/2020
1NDC:67777-319-020.13 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/01/2020
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Hobi Kozmetic Imalat Sanayi Ve Ticaret Anonim Sirketi533139227manufacture(67777-319)

Revised: 11/2022
Document Id: eeb7c7cf-3723-d892-e053-2995a90a00c6
Set id: ab0d5f64-9168-2ea3-e053-2a95a90a321e
Version: 3
Effective Time: 20221130
 
Dynarex Corporation