ANTIBACTERIAL HAND PROBLEND- chloroxylenol soap

Antibacterial Hand Problend by

Drug Labeling and Warnings

Antibacterial 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

Chloroxylenol 0.40%................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
• SODIUM LAURETH SULFATE
• LAURYL GLUCOSIDE
• COCAMIDOPROPYL BETAINE
• PROPYLENE GLYCOL
• COCO GLUCOSIDE
• GLYCERYL MONOOLEATE
• SODIUM CHLORIDE
• DMDM HYDANTOIN
• FD and C BLUE # 1
• FRAGRANCE

REFERENCES

• Manufactured by
• Seatex Ltd
• 445 TX Hwy 36
• Rosenberg
• Tx 77471

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND PROBLEND  
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76250-786
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	4 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76250-786-04	4 in 1 CARTON
1	NDC: 76250-786-01	3790 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	05/31/2011

Labeler - Seatex Ltd (026647404)

Registrant - Seatex Ltd (026647404)

Establishment
Name	Address	ID/FEI	Business Operations
Seatex Ltd		026647404	manufacture(76250-786)