SaniSuds Antibacterial Foam by Palmer Fixture Company

SaniSuds Antibacterial Foam by

Drug Labeling and Warnings

SaniSuds Antibacterial Foam by is a Otc medication manufactured, distributed, or labeled by Palmer Fixture Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SANISUDS ANTIBACTERIAL FOAM- chloroxylenol soap 
Palmer Fixture Company

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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​Active Ingredient

Chloroxylenol 0.75% w/w

​Purpose

Skin Antimicrobial   

​Use

reduces amount of bacteria on hands

​Warnings

For external use only.  Do not use in eyes.

Discontinue use if irritation and redness develop.  If condition persists for more than 72 hours, consult a physician.

Not for use on children under six months of age.

For institutional and professional use only.

​Directions

• Wet hands and forearms.
• Apply a small amount or palmful to hands and forearms.
• Scrub thoroughly for at least fifteen seconds.
• Rinse completely and dry.

​Inactive Ingredients

Water, Propylene Glycol, TEA-Lauryl Sulfate, Lauramide DEA, Fragrance, DMDM Hydantoin, Yellow 5, Blue 1

SANISUDS ANTIBACTERIAL FOAM 
chloroxylenol soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 48417-713
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)	CHLOROXYLENOL	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE LAURYL SULFATE (UNII: E8458C1KAA)
LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)
DMDM HYDANTOIN (UNII: BYR0546TOW)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	green	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 48417-713-03	3 in 1 BOX	01/05/2017	02/28/2020
1		1200 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/05/2017	02/28/2020

Labeler - Palmer Fixture Company (185454241)

Revised: 10/2018

Document Id: 1978a5d5-c70e-42a5-a4be-98b74d16f20b

34390-5

Set id: 8e3a8e00-a650-4247-ab79-6a74ea2f9a7f

Version: 2

Effective Time: 20181030