COMFORTLAB™ HAND SANITIZING Wipes

COMFORTLAB Hand Sanitizing wipes by

Drug Labeling and Warnings

COMFORTLAB Hand Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by Sam Salem & Son, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMFORTLAB HAND SANITIZING WIPES- benzalkonium chloride swab 
Sam Salem & Son, 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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COMFORTLAB™ HAND SANITIZING Wipes

Active ingredient

Benzalkonium Chloride 0.156%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use:

In the eyes.

If you are allergic to any of the ingredients.

When using this product if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right way.

Directions

• To Storage: Store at room temperature.
• To Dispense: Peel back front label slowly. Remove wipes.
• To Reseal: Firmly press down over the label.
• To Use: Apply to hands thoroughly. Allow to dry without wiping.
• To Dispense: Place in trash basket after use. Do not flush.

Other informations

Wipe Dimensions:

7.87IN*5.9IN (20cm*15cm)

Date of Production: See code on the base of pack

Shelf life: 36 months

Inactive ingredients

Aloe Vera Barbadensis Extract, Bronopol, Citric acid, Didecyldimonium Chloride, Iodopropynyl Butylcarbamate, Monohydrate, Propylene Glycol, Polysorbate20, Water.

KILLS 99.9% OF GERMS

ENRICHED WITH ALOE VERA

2 in 1 

HAND & SKIN SURFACES

SECURE LOCK SEAL

Keeps wipes moist

NYC

Made in China

Packaging

COMFORTLAB HAND SANITIZING WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80730-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.156 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BRONOPOL (UNII: 6PU1E16C9W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80730-015-10	10 in 1 BAG	10/18/2020	12/27/2022
1		6.1 g in 1 PACKAGE; 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	part333A	10/18/2020	12/27/2022

Labeler - Sam Salem & Son, LLC (105092738)

Revised: 12/2022

Document Id: 5e62ba16-3fd2-4d7d-b8e0-aaf13e74d406

34390-5

Set id: 375cf2bf-4683-443a-b99d-bd48202e672d

Version: 2

Effective Time: 20221228