ANTIBACTERIAL HAND MILK AND HONEY SCENTED- chloroxylenol liquid
PANROSA ENTERPRISES, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Antibacterial Hand Soap Milk and Honey Scented

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.

If pregnant or breast-feeding,

ask a health professional before use.

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, Glycerin, Glycol Stearate, Sodium Chloride, Peg-150 Distearate, Citric Acid, Fragrance, Methylisothiazolinone Methylchloroisothiazolinone, Disodium EDTA

Package Labeling:

Alt Label Design milk_honey_soap

ANTIBACTERIAL HAND MILK AND HONEY SCENTED
chloroxylenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50302-510
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOL STEARATE (UNII: 0324G66D0E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
EDETATE DISODIUM (UNII: 7FLD91C86K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50302-510-00	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2016

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

Labeler - PANROSA ENTERPRISES, INC. (859957578)