HAND ANTIBACTERIAL- chloroxylenol soap

Hand Antibacterial by

Drug Labeling and Warnings

Hand Antibacterial by is a Otc medication manufactured, distributed, or labeled by PANROSA ENTERPRISES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antibacterial

Uses

• for handwashing 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 with water.

Stop use and ask a doctor if

• irritation and redness develops.

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 leat 15 seconds
• wash skin, rinse and dry thoroughly

Inactive Ingredients:

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Cocamide MEA, Sodium Chloride, Glycerin, Disodium EDTA, PEG-150 Distearate, Citric Acid, Fragrance (Parfum), Methylisothiazolinone, Methylchloroisothiazolinone, FD&C Yellow No. 5, FD&C Red No. 4.

Package Labeling:

INGREDIENTS AND APPEARANCE

HAND ANTIBACTERIAL 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50302-540
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50302-540-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2016
2	NDC: 50302-540-01	710 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/20/2016

Labeler - PANROSA ENTERPRISES, INC. (859957578)