PANROSA ANTIBACTERIAL BAR- chloroxylenol soap
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.

----------

Panrosa Antibacterial Bar Soap

Drug Facts

Active ingredient

Chloroxylenol 0.25%

Purpose

Antibacterial

Uses

For 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 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

wet bar with water
lather vigorously and wash skin
rinse and dry thoroughly

Inactive ingredients

SODIUM COCOATE, SODIUM PALMATE, WATER, GLYCERIN, SODIUM CHLORIDE, TITANIUM DIOXIDE, BHT, EDTA, FRAGRANCE, TRICLOCARBAN, RETINYL PALMITATE , TOCOPHERYL ACETATE,FD&C YELLOW NO. 5, FD&C RED NO. 4

Package Labeling:

Bottle4

PANROSA ANTIBACTERIAL BAR
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50302-014
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 g

Ingredient Name	Strength
Inactive Ingredients
SODIUM COCOATE (UNII: R1TQH25F4I)
SODIUM PALMATE (UNII: S0A6004K3Z)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
EDETIC ACID (UNII: 9G34HU7RV0)
TRICLOCARBAN (UNII: BGG1Y1ED0Y)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50302-014-90	90 g in 1 BOX; Type 0: Not a Combination Product	06/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/15/2020

Labeler - Panrosa Enterprises, Inc. (859957578)