GEA COSMETICS LABS HAND AND BODY SANITIZER- benzalkonium chloride 0.13% spray 
Romano Group, 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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GEA Cosmetics Labs Hand & Body Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

Hand Sanitizer to to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For External Use only.

Do Not Use

On children less that 2 months of age

on open skin wounds

When using this product

keep out of eyes, ears, and mouth, in case of contact with eyes, rinse eyes thoroughly with water

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other Information

Store between 15-30C (59-86F)
Avoid Freezing and excessive heat above 40C (104F)

Inactive Ingredients

Ionized water, Carbamide

GEA Cosmetics Labs Hand & Body Sanitizer

labellabel

GEA COSMETICS LABS HAND AND BODY SANITIZER 
benzalkonium chloride 0.13% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81237-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.61 g  in 472 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
UREA (UNII: 8W8T17847W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81237-001-16472 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
2NDC:81237-001-103785 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2021
Labeler - Romano Group, LLC (037493262)

Revised: 1/2021
Document Id: b6fbff99-6710-6837-e053-2a95a90a6d7f
Set id: b6fc0cc8-fefb-6835-e053-2a95a90a899c
Version: 1
Effective Time: 20210101
 
Romano Group, LLC