Derma Sanitizer by Insight Pharmaceuticals LLC Derma Sanitizer

Derma Sanitizer by

Drug Labeling and Warnings

Derma Sanitizer by is a Otc medication manufactured, distributed, or labeled by Insight Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMA SANITIZER- benzalkonium chloride liquid 
Insight Pharmaceuticals LLC

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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Derma Sanitizer

Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

Helps eliminate bacteria on hands

Warnings

For external use only

When using this product

avoid contact with eyes. In case of contact, rinse eyes thoroughly with water immediately.

Stop use and ask doctor if

irritation or redness develops.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Children under 6 should be supervised when using this product. Not recommended for infants.

Use enough product on hands to cover all surfaces. Rub hands together until dry without wiping. Do not rinse.

Other information

Store at room temperature Avoid excessive heat.

Inactive ingredients

aloe vera leaf, edetate disodium, ethanol, nonoxynol-9, propylene glycol, water

Questions?

1-800-344-7239

Principal Display Panel

Derma Sanitizer™

Spray Hand Sanitizer

6 FL OZ (177 mL)

DERMA SANITIZER 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63736-313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALCOHOL (UNII: 3K9958V90M)
NONOXYNOL-9 (UNII: 48Q180SH9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63736-313-06	177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/01/2020	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	11/01/2020	11/01/2020

Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 11/2020

Document Id: 94478b26-46fc-4caf-85e7-a137a94ac528

34390-5

Set id: 605e438f-2452-488e-a736-2592a14958fd

Version: 2

Effective Time: 20201109