Drug Facts 416

Drug Facts 416

Drug Labeling and Warnings

Drug Details

k">

HAND WASH- benzalkonium chloride liquid 
Meijer Distribution

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.

----------

Drug Facts 416

Active ingredient

Benzalkonium chloride 0.13%

purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

warnings

For external use only-hands only

When using this product

  • avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops
  • 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

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, orange 4, red 33

Questions

Call 1-888-593-0593

Adverse reactions

DIST. BY

MEIJER DISTRIBUTION, INC

GRAND RAPIDS, MI 49544

www.meijer.com

416.000/416AA rev 1

principal display panel

meijer

NEW PUMP

FOAMING

hand

soap

Antibacterial

ENERGY BERRY

7.5 FL OZ

(221 mL)

image description

HAND WASH 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 41250-596
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SULISOBENZONE (UNII: 1W6L629B4K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 41250-596-96221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/06/2014
2NDC: 41250-596-45946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/06/2014
Labeler - Meijer Distribution (006959555)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(41250-596)

Revised: 1/2020
 
Meijer Distribution


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.