Label: BLUE ACME SLEEVE FIRST AID CONTAINS 1000 PIECES- benzalkonium chloride, lidocaine, benzalkonium chloride, water, isopropyl alcohol, aspirin, bacitracin zinc,neomycin sulfate,polymyxin b sulfate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 7, 2010

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Benzalkonium Chloride 0.13%
    Lidocaine HCL 0.5%

  • PURPOSE

    Purpose: First aid antiseptic, external analgesic

    Uses: First aid to help prevent infection and for the temporary relief of pain and itching associated with:

    Minor Cuts

    Scrapes

    Burns

  • WARNINGS

    Warnings:

    For external  use only

  • DO NOT USE

    Do not use: In eyes, in large quantities, over raw blistered areas, or on deep puncture wounds, animal bites or serious burns, for more than one week

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children.

    If ingested, contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Clean affected area, Apply small amount not more than 3 times daily.

    May be covered with a sterile bandage.

  • STORAGE AND HANDLING

    Other Information:

    Store at room temperature

  • PRINCIPAL DISPLAY PANEL

    Genuine First Aid Burn Cream

    Antiseptic Pain Relief With Aloe

    Net Wt 0.9g (1/32 oz)

    Manufactured in CHINA for

    Genuine First Aid.

  • PRINCIPAL DISPLAY PANEL

    BurnCream

  • ACTIVE INGREDIENT

    Active Ingredient:                                            Purpose

    Benzalkonium Chloride 0.40%..........    First Aid Antiseptic

  • PURPOSE

    Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

  • WARNINGS

    Warning:    For external use only.

  • 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.

  • STOP USE

    Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

  • DO NOT USE

    Do not use in the eyes or over large areas of the body.

  • WHEN USING

    Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

  • INACTIVE INGREDIENT

    Inactive Ingredient:    Purified water

  • DESCRIPTION

    LOT/EXP:                                    Made in CHINA

    20130301

  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

  • ACTIVE INGREDIENT

    Active Ingredient: .........Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

  • PURPOSE

    Uses:  To help prevent infection in:
    minor cuts;  scrapes;  burns

  • WARNINGS

    Warnings:

    For external use only.

  • DO NOT USE

    Do not use:  in eyes;  over large areas of the body;

    If allergic to any of the ingredients;  for more than one week unless directed by a physician.

  • STOP USE

    Stop use and consult a doctor:

    if the condition persists or gets worse;  a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

  • WHEN USING

    Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

  • PRINCIPAL DISPLAY PANEL

    Genuine Triple Antibiotic

    First Aid Ointment

    To Help Prevent Infection

    Each Gram Contains:

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg

    (equivalent to 3.5 mg

    Neomycin base)

     Polymyxin B Sulfate 5000 units

    Net Wt. 0.5g ; (1/64 oz)

    Manufactured in CHINA for

    GENUINE FIRST AID.

  • PRINCIPAL DISPLAY PANEL

    GenuineTripleAntibiotic

  • ACTIVE INGREDIENT

    Active Ingredient:

    Purified Water USP...q.s.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Sodium Chloride USP                                          44mg

    Monobasic Sodium Phosphate USP                18mg
    Sodium Phosphate Dibasic USP                       111mg  

    Edetate Disodium USP                                       10mg

    Benzalkonium Chloride                                      0.5mg
    NF (as preservative)

  • STORAGE AND HANDLING

    Store in a cool place. For irrigation only.

    Discard unused portion of the solution.

    Not for injection.

  • WARNINGS

    Warning:

    If you experience eye pain, changes in vision, continued redness or irritation of the eye,

    or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

    Do not use if solution changes color or becomes cloudy.

  • DOSAGE & ADMINISTRATION


    Directions

    Remove contacts before using.

    Twist top to remove.

    Flush the affected area as needed. Control

    Rate of flow by pressure on the bottle. Do not touch

    tip of the container to any surface. Do not reuse.

    If necessary continue flushing with emergency eyewash or shower.

    Discard bottle after use.

  • PURPOSE

    Uses:

    For flushing or irrigating the eyes to

    remove loose foreign material, air pollutants,

    or chlorinated water.

  • DESCRIPTION

    Code No.: GUJ/DRUG/G/1080

    Batch No.:

    Mfg Date:

    Exp: Date:

  • PRINCIPAL DISPLAY PANEL

    10ml

    Sterile Isotonic Buffered Genuine

     Eyewash

    For single use only

  • PRINCIPAL DISPLAY PANEL

    GenuineEyeWash

  • ACTIVE INGREDIENT

    Active Ingredient:                                        Purpose

    Isopropyl Alcohol, 70% v/v...............        Antiseptic

  • PURPOSE

    Use:    For preparation of skin before injection.

  • WARNINGS

    Warnings:    For external use only.   

  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame

    Store at room temperature 15-30 degree Celsius (59-86 degree Fahrenheit)

  • DO NOT USE

    Do not use: with electrocautery, in the eyes.

  • STOP USE

    Stop use if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

  • 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.

  • WHEN USING

    Wipe Injection site vigorously and discard.

  • INACTIVE INGREDIENT

    Inactive Ingredient:    Purified water.

  • DESCRIPTION

    LOT/EXP:                Made in CHINA

    20140301

  • PRINCIPAL DISPLAY PANEL

    Alcohol Cleansing  Pad
    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

  • PRINCIPAL DISPLAY PANEL

    AlcoholCleansingPad

  • ACTIVE INGREDIENT

    Active Ingredient:                                    Purpose:

    Benzocaine, 6% w/v..................    Topical Anesthetic

    SD alcohol, 60% w/v..................    Antiseptic

  • PURPOSE

    Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

  • WARNINGS

    Warnings: For external use only.

    Avoid contact with eyes.  If this happens, rinse thoroughly with water.

  • 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.

  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame.

  • DO NOT USE

    Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

  • DESCRIPTION

    Made in CHINA

    LOT/EXP:

  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad

    Genuine First Aid LLC, Clearwater FL 33755
                            www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad

  • ACTIVE INGREDIENT

    Active ingredient (in each tablet)                           Purpose

    Aspirin 81 mg (NSAID*). . . . . . . . . . . . . Analgesic/Antipyretic

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

    Uses

    temporary relief of minor aches, pains and headaches

    to reduce fever associated with colds, sore throats, teething

  • WARNINGS

    Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of reye's syndrome, a rare but serious illness.
    Stomach bleeding warning:  This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding.  The chance is higher if the user; has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed is age 60 or older has 3 or more alcoholic drinks every while using this product.

  • DO NOT USE

    Do not use

    if you are allergic to aspirin or any other pain relievers/fever reducers

    for more than 10 days for pain unless directed by a doctor

    for more than 3 days for fever unless directed by a doctor

    for at least 7 days after a tonsillectomy or oral surgery

  • ASK DOCTOR

    Ask a doctor before use if you have;

    asthma

    stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, ulcers or bleeding problems

    a child experiencing arthritis pain

    if you are;

    allergic to aspirin

    taking prescription drug for anticoagulation (thinning of blood), diabetes, gout or arthritis

  • STOP USE

    Stop use and ask a doctor if;

    an allergic reaction occurs, Seek medical help right away

    pain or fever persists

    new or unexpected symptoms occur

    redness or swelling is present

    ringing in ears or loss of hearing occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.  It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions  Do not use more than directed

    Adults and Children (12 years and older): Chew 4 to 8 tablets with water every 4 hours,  Do not exceed 48 tablets in 24 hours unless directed by a doctor.

    Children Under 12 years: Consult a doctor.

  • STORAGE AND HANDLING

    Store at room temperature

    tamper evident sealed packets

    do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive ingredients        flavor, FD and C yellow No. 6, saccharin, sodium, silicon dioxide, starch, stearic acid, sucrose

  • DESCRIPTION

    MADE IN USA

    Distributed by GENUINE FIRST AID

    600 Cleveland Str Suite 400, Clearwater, FL 33755

  • PRINCIPAL DISPLAY PANEL

     2 Tablets

    GENUINE FIRST AID.

    Chewable Aspirin 81mg

  • PRINCIPAL DISPLAY PANEL

    Chewable Aspirin 81mg

  • PRINCIPAL DISPLAY PANEL

    PhysiciansCARE

    FIRST AID
    all purpose kit
    with 6 First Aid Pockets

    1 Small Cuts and Burns

    2 Medium Cuts and Scratches

    3 Severe Bleeding and Burns

    4 CPR

    5 Protection

    6 Instruments

    New
    REFILL PACKS AVAILABLE FOR EACH POCKET

    HOME        PLAY    AUTO     OFFICE    WORK  

    CONTAINS 1000 PIECES

    Soft-Sided Storage Case

    With Pockets that are Organized for Quick and Easy Emergency Access

    CARRYING CASE
    1 Soft-side Bag
    1 Inside Plastic Pockets

    SMALL CUTS AND BURNS
    Pocket One
    300 Adhesive Plastic Bandages 3/4"x3"
    295 Junior Plastic Bandages 3/8"x1-1/2"
    90 Adhesive Plastic Bandages 1"x3"
    5 Knuckle Fabric Bandages
    180 Adhesive Spot Bandages 7/8"x7/8"
    6 Fingertip Fabric Bandages
    6 Elbow/Knee Adhesive Bandage
    1 Burn Cream
    14 Antiseptic Towelettes
    4 Triple Antibiotic Ointment
    6 Sterile Gauze Pads 2''x2''
    20 Cotton Tipped Applicatiors


    MEDIUM CUTS AND SCRATCHES
    Pocket Two
    12 Antiseptic Towelettes
    5 Sterile Gauze Pad 2"X2"
    2 Sterile Gauze Pad 3"x3"
    2 Sterile Gauze Pad 4"x4"
    2 Roll Gauze Bandages 2"
    2 Sterile Eye Pads
    2 Sterile Eye Wash
    5 Butterfly Wound Closures


    SEVERE BLEEDING AND BURNS
    Pocket Three
    1 First Aid Tape Roll 1/2"
    1 Combine Pad 5"x9"
    1 Combine Pad 8"x10"
    1 Roll Gauze Bandage 3"

    CPR
    Pocket Four
    1 CPR Breathing Barrier

    PROTECTION
    Pocket Five
    4 Medical Grade  Gloves
    1 Instant Cold Compress
    10 Alcohol Cleansing Pads
    2 Insect Sting Relief Pads
    1 Emergency Blanket 38"X 60"
    4 Chewable Aspirin Tablets
    1 Triangular Bandage 42"x42"x59"

    INSTRUMENTS
    Pocket Six
    1 Emergency First Aid Guide
    1 Plastic Tweezers
    1 Scissors
    6 Assorted Safety Pins
    2 Wooden Finger Splints

    CAUTION: This kit contains products that have expiration dates. Please check before using.

    Acme United Corporation
    60 Round Hill Road
    Fairfield, CT 06824
    www.acmeunited.com
    Designed in USA / Made in India
    2009 Acme United Corporation
    PhysiciansCare and are Registered Trademrks
    of Acme United Corporation


  • PRINCIPAL DISPLAY PANEL

    ACME Blue Sleeve 1000 KIT

  • INGREDIENTS AND APPEARANCE
    BLUE ACME SLEEVE FIRST AID CONTAINS 1000 PIECES 
    benzalkonium chloride, lidocaine, benzalkonium chloride, water, isopropyl alcohol, aspirin, bacitracin zinc,neomycin sulfate,polymyxin b sulfate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-1807
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-1807-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE 0.9 g
    Part 226 PACKAGE 20.8 mL
    Part 32 BOTTLE 20 mL
    Part 410 PACKAGE 5 mL
    Part 52 PACKAGE 1 mL
    Part 61 PACKAGE
    Part 74 TUBE 2 g
    Part 1 of 7
    GENUINE FIRST AID BURN ANTISEPTIC PAIN RELIEF WITH ALOE 
    benzalkonium chloride, lidocaine cream
    Product Information
    Item Code (Source)NDC:52124-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0004-10.9 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34504/27/2010
    Part 2 of 7
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/27/2010
    Part 3 of 7
    STERILE ISOTONIC BUFFERED GENUINE EYEWASH 
    water liquid
    Product Information
    Item Code (Source)NDC:52124-0005
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.16 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0005-110 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/27/2010
    Part 4 of 7
    ALCOHOL CLEANSING PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0002-10.5 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/27/2010
    Part 5 of 7
    INSECT STING RELIEF PAD 
    benzocaine,alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0008-10.5 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34804/27/2010
    Part 6 of 7
    CHEWABLE ASPIRIN 
    aspirin tablet, chewable
    Product Information
    Item Code (Source)NDC:52124-0012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SACCHARIN (UNII: FST467XS7D)  
    SODIUM CATION (UNII: LYR4M0NH37)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colororange (ORANGE) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0012-14 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34504/27/2010
    Part 7 of 7
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:52124-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-10.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/27/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/27/2010
    Labeler - Acme United Corp. (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production ( Xiamen) Co., Ltd421256261manufacture