LAFLARE SANTIX ANTIBACTERIAL MOISTURIZING WIPES- benzalkonium chloride liquid 
NAICO

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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Drug Facts

ACTIVE INGREDIENT

Benzalkonium Chloride 0.1%

INACTIVE INGREDIENTS

Water, Phenoxyethanol, Glycerin, Sodium Benzoate, Polysorbate 20, Disodium EDTA, Citric Acid, Tocopheryl Acetate, Macadamia Integrifolia/Tetraphylla Seed Oil, Anthemis Nobilis Flower Extract, Fragrance

PURPOSE

Antimicrobial

WARNINGS

For external use only.
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Do not use
• in children less than 2 months of age
• on open skin wounds
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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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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 Posion Control Center right away

Uses

Instant hand antimicrobial to decrease bacteria on the skin

Directions

■ Wet hands thoroughly with product and allow to dry without wiping

■ Do not flush

Other information

Storage in a cool, dry place, Avoid freezing and excessive heat above 40 ℃ (104 ℉)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of container

LAFLARE SANTIX ANTIBACTERIAL MOISTURIZING WIPES 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75536-0005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75536-0005-181 g in 1 CONTAINER; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/01/2020
Labeler - NAICO (694725335)
Registrant - NAICO (694725335)
Establishment
NameAddressID/FEIBusiness Operations
NAICO694725335manufacture(75536-0005)

Revised: 5/2020
Document Id: 99b7db8b-829a-4126-8294-41bfd1fe738d
Set id: 7b6f8f2f-c020-4ba6-85cb-d1f55f1169f9
Version: 1
Effective Time: 20200530
 
NAICO