Label: CALFARME FOAM CARE- benzalkonium chloride liquid

  • NDC Code(s): 70136-101-01, 70136-101-02, 70136-101-04
  • Packager: Calfarme (singapore) Pte.Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated October 19, 2019

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Concentrate: Benzalkonium Chloride 2.0 % 

    Use Dilution: Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    ■ cleans and sanitizes the hands
    ■ for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

    Flammable: Keep away from fire or flame.

    Do not use: ■ full strength. Dilute 1 part to 20 parts with Distilled water (50ml to 1,000ml with Distilled water).

    When using this product
    ■ do not get into eyes
    ■ if contact occurs, rinse eyes thoroughly with water
    ■ dilute with distilled water before use because acidic or hard water may render the product inactive

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ dilute 1 part FOAM CARE CONCENTRATE to 20 parts with Distilled water (50ml to 1,000ml with Distilled water).
    ■ formulated for used with manual or NO-TOUCH automatic foam pump dispenser.
    ■ pump a small amount of foam onto palm
    ■ rub and clean the hands well before rinse with water.

  • INACTIVE INGREDIENT

    Inactive Ingredients Cocoamidopropylbetaine, Coco Glucoside, Polyquaternium-7, Water.

  • ​Other Information

    ■ keep the container closed when not in use.
    ■ keep only in the original container in a cool, well ventilated place away from direct sunlight & heat sources.

  • QUESTIONS

    Questions? 855-884-4880 Toll Free

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY CALFARME (SINGAPORE) PTE LTD

    ISO 9001:2015 & ISO 14001:2015 Certified

    AMK TechLink, 20 Ang Mo Kio Industrial Park 2A #06-18

    Singapore 567761


    DISTRIBUTED BY CALFARME INC.

    11311 White Rock Road, Rancho Cordova, CA 95742

    MADE IN SINGAPORE

  • Packaging

    fm1

  • INGREDIENTS AND APPEARANCE
    CALFARME  FOAM CARE
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70136-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE20 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70136-101-044 in 1 CARTON10/06/2015
    13.78 L in 1 CAN; Type 0: Not a Combination Product
    2NDC:70136-101-0216 in 1 CARTON10/06/2015
    21.89 L in 1 CAN; Type 0: Not a Combination Product
    3NDC:70136-101-0112 in 1 CARTON10/06/2015
    30.945 L in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2015
    Labeler - Calfarme (singapore) Pte.Ltd (595222746)
    Establishment
    NameAddressID/FEIBusiness Operations
    Calfarme (singapore) Pte.Ltd595222746manufacture(70136-101)