1438 DYNASOAP- antibacterial hand soap soap

1438 DynaSoap by

Drug Labeling and Warnings

1438 DynaSoap by is a Otc medication manufactured, distributed, or labeled by Dynarex Corporation, Hobi Kozmetic Imalat Sanayi Ve Ticaret Anonim Sirketi. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Label

INGREDIENTS AND APPEARANCE

1438 DYNASOAP 
antibacterial hand soap soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67777-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67777-319-01	24 in 1 CASE	08/01/2020
1	NDC: 67777-319-02	0.13 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/01/2020

Labeler - Dynarex Corporation (008124539)

Registrant - Dynarex Corporation (008124539)

Establishment
Name	Address	ID/FEI	Business Operations
Hobi Kozmetic Imalat Sanayi Ve Ticaret Anonim Sirketi		533139227	manufacture(67777-319)