OTC Medication Information: K Boom Hand Cream

K BOOM HAND CREAM- benzalkonium chloride cream
MLS

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.

Active ingredient[s]

Benzalkonium Chloride 0.05%

Purpose

Antimicrobial

Use[s]

Hand Sanitizer to help reduce bacteria that potentially can casuse disease.

Warnings

For external use only. Flammable.Keep away from heat or flame.

Do not use

• in children less than 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.

Stop use and ask a doctor

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

Keep out of reach of children.

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

Directions

• 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.

Other information

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

Inactive ingredients

Water, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Hydrogenated Polydecene, Glyceryl Stearate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Butylene Glycol, 1,2-Hexanediol, Arginine, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Collagen, Olea Europaea (Olive) Fruit Oil, Squalane, Hydrogenated Lecithin, Ceramide NP, Cholesterol, Phytosphingosine, Illicium Verum (Anise) Fruit Extract, Caprylyl Glycol, Ethylhexylglycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Stearyl Alcohol, Myristyl Alcohol, Lauryl Alcohol, Glyceryl Stearate SE, Sorbitan Stearate, Glyceryl Stearate Citrate, Disodium EDTA

Package Label

K BOOM HAND CREAM benzalkonium chloride cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73984-337 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.05 mg in 100 mL

Inactive Ingredients Ingredient Name Strength SQUALANE CHOLESTEROL PHYTOSPHINGOSINE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERYL STEARATE SE SORBITAN MONOSTEARATE WATER GLYCERIN MEDIUM-CHAIN TRIGLYCERIDES CETYL ALCOHOL HYDROGENATED POLYDECENE TYPE I 1,2-HEXANEDIOL GLYCINE SERINE GLUTAMIC ACID GLYCERYL MONOSTEARATE SHEA BUTTER SUNFLOWER OIL BUTYLENE GLYCOL CAPRYLYL GLYCOL ARGININE ISOLEUCINE MYRISTYL ALCOHOL CERAMIDE NP CARBOMER INTERPOLYMER TYPE A (55000 CPS) LAURYL ALCOHOL GLYCERYL STEARATE CITRATE EDETATE DISODIUM ANHYDROUS CYSTEINE LEUCINE LYSINE THREONINE PROLINE HISTIDINE HYDROGENATED SOYBEAN LECITHIN STAR ANISE FRUIT ETHYLHEXYLGLYCERIN STEARYL ALCOHOL PHENYLALANINE ASPARTIC ACID ALANINE TYROSINE VALINE METHIONINE MARINE COLLAGEN, SOLUBLE OLIVE OIL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73984-337-04 60 mL in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/17/2020

Labeler — MLS (689850283)

Registrant — MLS (689850283)

Establishment
Name	Address	ID/FEI	Operations
MLS		689850283	manufacture (73984-337)

Revised: 12/2020 MLS