Hand Sanitizer by Broder Bros Prime Line / Bath Concept Cosmetics (Dongguan) Co., Ltd Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Broder Bros Prime Line, Bath Concept Cosmetics (Dongguan) Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol gel 
Broder Bros Prime Line

----------

Hand Sanitizer

Drug Facts

Active ingredient

Alcohol 62%

Purpose

Antiseptic

Use

for hand-washing to decrease bacteria on the skin, only when water is not available

Warnings

For external use only

Flammable, keep away from fire and flames.

When using this product

  • do not get into eyes.
  • if contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

  • irritation and redness develop

Keep out of reach of children.

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping

Inactive Ingredients

Aminomethyl Propanol, Carbomer, Water.

Package Labeling:

Label

HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71513-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71513-210-00240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/18/202007/31/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)06/18/202007/31/2022
Labeler - Broder Bros Prime Line (107044246)
Establishment
NameAddressID/FEIBusiness Operations
Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(71513-210)

Revised: 10/2024
 

Trademark Results [Hand Sanitizer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAND SANITIZER
HAND SANITIZER
88958909 not registered Live/Pending
MAISON BLANCHE, LLC
2020-06-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.