ANTI BACTERIAL FOAM HAND PROBLEND- benzalkonium chloride soap

Anti Bacterial Foam Hand Problend by

Drug Labeling and Warnings

Anti Bacterial Foam Hand Problend by is a Otc medication manufactured, distributed, or labeled by Seatex Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient................Purpose

Benzalkonium Chloride 0.13%................Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product

• avoid contact with eyes
• In case of eye contact
• flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if 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

• Pump into hands, wet as needed.
  
• Lather vigorously for at least 15 seconds
  
• Wash skin, rinse thoroughly and dry.

Inactive Ingredients

• WATER
• BUTYLENE GLYCOL
• DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE
• DIHYDROXYETHYL COCAMINE OXIDE, GLYCERETH-2 COCOATE
• HYDROXYPROPYL METHYLCELLULOSE
• FD and C BLUE # 1

REFERENCES

• Manufactured By
  
• Seatex Ltd
  
• 445 TX Hwy 36
  
• Rosenberg
• TX
• 77471

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTI BACTERIAL FOAM HAND PROBLEND  
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76250-995
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 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76250-995-02	2 in 1 CARTON
1	NDC: 76250-995-04	4 in 1 CARTON
1	NDC: 76250-995-01	3780 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/31/2012

Labeler - Seatex Ltd (026647404)

Registrant - Seatex Ltd (026647404)

Establishment
Name	Address	ID/FEI	Business Operations
Seatex Ltd		026647404	manufacture(76250-995)