ANTIBACTERIAL- chloroxylenol soap

Antibacterial by

Drug Labeling and Warnings

Antibacterial 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%................Antimicrobial

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

REFERENCES

Manufactured by Seatex Ltd, Rosenberg,Texas 77471

PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76250-1195
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	40 g  in 1 kg

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 MONOOLEATE (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: 76250-1195-4	4 in 1 CARTON
1	NDC: 76250-1195-1	3.78 kg in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/14/2011

Labeler - Seatex Ltd (026647404)

Establishment
Name	Address	ID/FEI	Business Operations
Seatex Ltd		026647404	manufacture