Bactakleen Ultra Mist

Bactakleen Ultra Mist

Drug Labeling and Warnings

Drug Details

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BACTAKLEEN ULTRA MIST- benzalkonium chloride liquid 
Excelsia Technologies Sdn Bhd

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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Bactakleen Ultra Mist

Active Ingredients

Benzalkonium chloride (0.1%)

Purpose

Antibacterial

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Uses

For sanitizing to decrease bacteria

Warnings

For external use only

Do not use if you are allergic to any of the ingredients

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

Directions

Spray adequate amount to desired area.

Inactive Ingredients

Distilled water, Vegetable Oil, Pine Oil, Salvia Officinalis (Sage) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil

Bactakleen Ultra Mist

Bactakleen Ultra Mist

BACTAKLEEN ULTRA MIST 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73215-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.03 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SAGE OIL (UNII: U27K0H1H2O)  
TEA TREE OIL (UNII: VIF565UC2G)  
WHITE PINE OIL (UNII: HA5CX6676U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73215-105-021 in 1 BOX03/11/2020
1NDC: 73215-105-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/11/2020
Labeler - Excelsia Technologies Sdn Bhd (659311797)
Registrant - Excelsia Technologies Sdn Bhd (659311797)
Establishment
NameAddressID/FEIBusiness Operations
MBH Cosmeceutical Sdh Bhd659311739manufacture(73215-105)

Revised: 3/2020
 
Excelsia Technologies Sdn Bhd


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