B.clean Hand Sanitizer (foam): Package Insert and Label Information

B.CLEAN HAND SANITIZER (FOAM)- benzalkonium chloride gel
Marque of Brands Americas, 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.

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

Benzalkonium Chloride

Purpose

Antimicrobial

  • Place enough product on hands to cover all surfaces. Rub hands together until dry
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Sodium Methyl Cocoyl Taurate, Phenoxyethanol, Citric Acid, Fragrence

Warning

  • Flammable, keep away from flame.
  • For External Use Only.

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

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse throughly with water.

  • in children less than 2 months of age
  • on open skin wounds

and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

label

B.CLEAN HAND SANITIZER (FOAM)
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.25 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE
DISODIUM LAURETH SULFOSUCCINATE
SODIUM COCOYL ISETHIONATE
COCAMIDOPROPYL BETAINE
SODIUM METHYL COCOYL TAURATE
PHENOXYETHANOL
CITRIC ACID MONOHYDRATE
WATER
ALPHA-TOCOPHEROL ACETATE
SQUALANE
PROPYLENE GLYCOL
GLYCERIN
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73978-002-01 29 mL in 1 BOTTLE, PLASTIC None
2 NDC:73978-002-02 177 mL in 1 BOTTLE, PUMP None
3 NDC:73978-002-03 946 mL in 1 BOTTLE, PUMP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/30/2020
Labeler — Marque of Brands Americas, LLC (081170908)
Establishment
Name Address ID/FEI Operations
Marque of Brands Americas, LLC 081170908 manufacture (73978-002)

Revised: 03/2020 Marque of Brands Americas, LLC

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