Label: REFILL 6- alcohol, water kit

  • NDC Code(s): 49687-0010-1, 49687-0015-0, 49687-0019-0
  • Packager: CMC Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Drug Facts - Hand Sanitizer

  • Active ingredient

    Ethyl alcohol 62%

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.
  • Warnings

    Flammable, keep away from fire or flameFor external use only.

    Do not use

    • in the eyes.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
  • Other information

    Store at 15° to 25°C (59° to 77°F)

  • Inactive ingredients

    Carbomer, propylene glycol, purified water, titanium dioxide

  • Drug Facts - Eye Wash

  • Active ingredient

    Purified Water 99.1%

    Purpose

    Eyewash

  • Use

    For cleansing the eye to help relieve irritation or burning by removing loose foreign material

  • Warnings

    For external use only.

    Do not use

    if solution changes color or becomes cloudy

    When using this product

    • to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

    Stop use and ask a doctor if

    • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

    Keep out of reach of children.

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

  • Directions

    • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

  • Other information

    • not for use as contact lens solution

    • use before expiration date marked on the bottle

    • store at room temperature, 5° to 35°C (41° to 95°F)

  • Inactive ingredients

    Benzalkonium chloride, sodium chloride

  • Hand Sanitizer (49687-0015-0) Labeling:

    Hand sanitizer

  • Eye Wash (50814-010-01) Labeling:

    Eye wash

  • Refill 6 (49687-0019-0) Labeling:

    Refill 6

  • INGREDIENTS AND APPEARANCE
    REFILL 6 
    alcohol, water kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0019
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0019-01 in 1 KIT08/10/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 16 BOTTLE 5.4 g
    Part 21 TUBE 30 mL
    Part 1 of 2
    HAND SANITIZER 
    alcohol gel
    Product Information
    Item Code (Source)NDC:49687-0015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0015-06 in 1 KIT
    10.9 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/10/2016
    Part 2 of 2
    EYE WASH 
    water solution
    Product Information
    Item Code (Source)NDC:49687-0010
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER991 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0010-11 in 1 BOX
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01808/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart33308/10/2016
    Labeler - CMC Group, Inc. (117201448)
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