SANISUDS FOAM HAND SANITIZER- benzalkonium chloride 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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SaniSuds Foam Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria on the skin
Recommended for repeated use

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 a small amount of foam into palm of hand.
Rub thoroughly over all surfaces of both hands.
Rub hands together briskly until dry.

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance

Case Label - 3 x 1000 mL Bags

SANISUDS FOAM HAND SANITIZER
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:48417-750
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.00 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)

Product Characteristics
Color	white (water white - colorless, dispensed as a white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:48417-750-02	3 in 1 BOX	04/07/2009	07/31/2022
1		1200 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC:48417-750-03	3 in 1 BOX	11/13/2020	12/31/2022
2		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/07/2009	12/31/2022

Labeler - Palmer Fixture Company (185454241)

Revised: 11/2021

Document Id: fd26de64-c63a-4ee5-adac-95acaa582503

Set id: 00d0e5b0-09aa-417f-9dc3-5dea59e57340

Version: 6

Effective Time: 20211130

Palmer Fixture Company