SANITEX ANTIBACTERIAL HAND WIPES CITRUS SCENT- benzalkonium chloride swab 
PREMIER CARE INDUSTRIES, INC

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  0.13%


Purpose

Antimicrobial

Uses

Warnings

For external use only.

Do not use if

you are allergic to any of these ingredients.


When using this product

avoid contact with eyes. In case of eye contact, flush eyes with water.


Stop use and ask a doctor

if irritation or redness develops, or if condition persists for more than 72 hours.


Keep out of the reach children.

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


Directions

For  40 Count wipes:




For 20 Count wipes:

            

            Adults and Children 2 Years and Over: Apply to hands and face. Allow to dry without wiping.

   

            Children Under 2 Years: Ask a doctor before use.



Other Information

Inactive ingredients

Purified Water, SD Alcohol 40, Phenoxyethanol, Decyl Glucoside, Potassium Sorbate, Sodium Benzoate, Disodium EDTA, Citric Acid, Aloe Barbadensis (Aloe) Leaf Extract, Fragrance


Principal Display Panel

Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

40 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

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Sanitex®

Antibacterial

HAND WIPES

Kills 99.9% of Germs

Enriched with Aloe

CITRUS SCENT

20 wipes| 5.6 inch x 7.5 inch (14.2 cm x 19.05 cm)

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SANITEX ANTIBACTERIAL HAND WIPES  CITRUS SCENT
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53118-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.26 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53118-001-0140 in 1 CANISTER
13 g in 1 PACKAGE; Type 0: Not a Combination Product
2NDC:53118-001-0220 in 1 BAG
23 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/18/2015
Labeler - PREMIER CARE INDUSTRIES, INC (858442403)
Establishment
NameAddressID/FEIBusiness Operations
PREMIER CARE INDUSTRIES, INC858442403manufacture(53118-001)

Revised: 6/2015
Document Id: 80bdd931-1ff8-467f-881b-be94a06adb25
Set id: 4df71478-5405-4980-8112-59d5f841627c
Version: 1
Effective Time: 20150618
 
PREMIER CARE INDUSTRIES, INC