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 25, 2018

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%

    Close
  • Purpose

    Antimicrobial

    Close
  • KEEP OUT OF REACH OF CHILDREN

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

    Close
  • Uses

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

    Close
  • 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.

    Close
  • 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.

    Close
  • INACTIVE INGREDIENT

    Inactive Ingredients Cocoamidopropylbetaine, Coco fatty acid diethanolamide, Fragrance, Sodium laureth sulfate, Water.

    Close
  • ​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.

    Close
  • QUESTIONS

    Questions? 855-884-4880 Toll Free

    Close
  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY CALFARME (SINGAPORE) PTE LTD

    ISO 9001:2008 & ISO 14001:2004 Certified

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

    Singapore 567761


    DISTRIBUTED BY CALFARME US INC.

    11311 White Rock Road, Rancho Cordova, CA 95742

    MADE IN SINGAPORE

    Close
  • Packaging
  • INGREDIENTS AND APPEARANCE
    CALFARME  FOAM CARE
    benzalkonium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70136-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 20 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70136-101-04 4 in 1 CARTON 10/06/2015
    1 3.78 L in 1 CAN; Type 0: Not a Combination Product
    2 NDC:70136-101-02 16 in 1 CARTON 10/06/2015
    2 1.89 L in 1 CAN; Type 0: Not a Combination Product
    3 NDC:70136-101-01 12 in 1 CARTON 10/06/2015
    3 0.945 L in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/06/2015
    Labeler - Calfarme (singapore) Pte.Ltd (595222746)
    Establishment
    Name Address ID/FEI Business Operations
    Calfarme (singapore) Pte.Ltd 595222746 manufacture(70136-101)
    Close