OTC Medication Information: B.clean Hand Sanitizer

B.CLEAN HAND SANITIZER- alcohol 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.

Ethyl Alcohol 60% v/v

Purpose

Antiseptic

  • 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, Carbomer, Fragrance, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane

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

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
(click image for full-size original)

B.CLEAN HAND SANITIZER
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:73978-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
WATER
ALPHA-TOCOPHEROL ACETATE
GLYCERIN
SQUALANE
PROPYLENE GLYCOL
ALOE VERA LEAF
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:73978-003-01 59 mL in 1 BOTTLE, PLASTIC None
2 NDC:73978-003-02 236 mL in 1 BOTTLE, PUMP None
3 NDC:73978-003-03 473 mL in 1 BOTTLE, PUMP None
4 NDC:73978-003-04 946 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 (73978-003)

Revised: 05/2020 Marque of Brands Americas, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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