K Boom Hand Cream by MLS 73984-337-01

K Boom Hand Cream by

Drug Labeling and Warnings

K Boom Hand Cream by is a Otc medication manufactured, distributed, or labeled by MLS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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73984-337-01

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.05 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ALCOHOL (UNII: 936JST6JCN)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCINE (UNII: TE7660XO1C)
SERINE (UNII: 452VLY9402)
GLUTAMIC ACID (UNII: 3KX376GY7L)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SHEA BUTTER (UNII: K49155WL9Y)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARGININE (UNII: 94ZLA3W45F)
ISOLEUCINE (UNII: 04Y7590D77)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CERAMIDE NP (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
LAURYL ALCOHOL (UNII: 178A96NLP2)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LEUCINE (UNII: GMW67QNF9C)
LYSINE (UNII: K3Z4F929H6)
THREONINE (UNII: 2ZD004190S)
PROLINE (UNII: 9DLQ4CIU6V)
HISTIDINE (UNII: 4QD397987E)
CYSTEINE (UNII: K848JZ4886)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
STAR ANISE FRUIT (UNII: CK15HA8438)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ASPARTIC ACID (UNII: 30KYC7MIAI)
ALANINE (UNII: OF5P57N2ZX)
TYROSINE (UNII: 42HK56048U)
PHENYLALANINE (UNII: 47E5O17Y3R)
VALINE (UNII: HG18B9YRS7)
METHIONINE (UNII: AE28F7PNPL)
MARINE COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)
OLIVE OIL (UNII: 6UYK2W1W1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73984-337-04	60 mL in 1 TUBE; Type 0: Not a Combination Product	12/17/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/17/2020	12/31/2021

Labeler - MLS (689850283)

Registrant - MLS (689850283)

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

Revised: 6/2022

Document Id: e0ffd530-f6f3-ef79-e053-2a95a90a2b8b

34390-5

Set id: b6a494d9-1f6a-a4d4-e053-2a95a90a42e4

Version: 2

Effective Time: 20220609