Label: MOUNTAIN SERIES WEEKENDER MEDICAL - benzalkonium chloride, povidone-iodine, acetaminophen, aspirin, diphenhydramine hydrochloride, ibuprofen, bacitracin zinc, neomycin sulfate, polymyxin b sulfate

  • NDC Code(s): 44224-0118-1, 47682-116-99, 47682-145-99, 47682-182-46, view more
    47682-808-99, 52124-0001-1, 52124-0003-1, 52380-0001-3
  • Packager: Tender Corporation dba Adventure Medical Kits
  • 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 August 1, 2011

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

  • Active Ingredient

    Active Ingredient:                        

    Benzalkonium Chloride 0.40%

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  • Purpose


    Antiseptic
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  • Use

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

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  • Warnings

    Warning:   For external use only.

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  • 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.

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  • STOP USE

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

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  • DO NOT USE

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

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  • Directions

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


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  • Inactive Ingredients

    Inactive Ingredient:   Purified water


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  • SPL UNCLASSIFIED SECTION

    LOT/EXP:                           Made in CHINA

    20130301

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  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

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  • Active Ingredients

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

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

    Polymyxin B Sulfate 5000 units

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  • Purpose

    Triple Antibiotic

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  • INDICATIONS & USAGE

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

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  • Warnings


    For external use only.

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  • 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.

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  • STOP USE

    Stop use and consult a doctor:

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

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

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  • Directions

    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

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  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

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  • Inactive Ingredient

    water Close
  • 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.



    Triple Antibiotic Ointment 10pcs

    Net wt. 0.9g (1/32oz)



    100
    Triple Antibiotic

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  • Active ingredient (in each tablet)

    Aspirin (NSAID*) 325 mg

    *nonsteroidal anti-inflammatory drug

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    Temporarily relieves minor aches and pains associated with

    • headache
    • minor arthritis
    • common cold
    • menstrual cramps
    • muscular aches
    • backache
    • toothache

    Temporarily reduces fever.

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  • 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription
      NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcohol drinks every day while
      using this product
    • take more or for a longer time than directed

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/ fever reducer
    • right before or after heart surgery
    • if you are taking prescription drugs for gout, diabetes or arthritis

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic

    Ask a doctor or pharmacist before use if you are

    • under a doctor's care for any serious condition
    • taking any other drug

    When using this product

    • take with food or milk if stomach upset occurs

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • pain gets worse or lasts more than 10 days
    • fever gets worse or lasts more than 3 days
    • you have difficulty swallowing
    • if ringing in the ears or loss of hearing occurs redness or swelling is present in the painful area
    • any new symptoms appear

    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 the unborn child or complications during delivery.

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

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  • Directions

    • do not take more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless
      directed by a doctor (see Warnings)
    • drink a full glass of water with each dose

    Adults and children: (12 years and older)

    Take 1 or 2 tablets with water every 4 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years:

    Do not give to children under 12 years of age.

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  • Other information

    • read all product information before using
    • store at room temperature 59º-86ºF (15º-30ºC)
    • avoid excessive heat and humidity
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • Inactive ingredients

    croscarmellose sodium*, hypromellose, microcrystalline cellulose*, mineral oil*, polyethylene glycol*, propylene glycol*, starch, titanium dioxide*

    *may contain

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  • Questions or comments?

    1-800-634-7680

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  • 116R Medique APAP 325 mg Label

    Medique®

    Aspirin

    5 Grain (325 mg)

    Pain Reliever/Fever Reducer (NSAID)

    See new warnings information

    East To Swallow

    Film Coated Tablets

    24 Tablets

    (12 x 2)

    Compare active ingredients to Bayer®

    Registered Trademark Bayer Consumer

    Tamper Evident Unit Dose Packets

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  • Active ingredients

    (in each capsule)

    Diphenhydramine Hydrochloride 25 mg

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  • Purpose

    Antihistamine

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  • Uses

    Temporarily relieves runny nose and decreases sneezing, itching of the nose and throat, itchy-watery eyes due to hay fever or other respiratory allergies.

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  • Warnings

    Do not use

    • with any other product containing diphenhydramine, even one that is used on skin.

    Ask a doctor before use if you have

    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • glaucoma

    Ask a doctor or pharmacist before use if you are

    • taking any drugs for asthma
    • taking sedatives or tranquilizers

    When Using This Product

    • marked drowsiness may occur
    • avoid alcohol beverages
    • alcohol, sedatives and tranquilizers may increase the drowsiness effect
    • use caution when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    If pregnant or breast feeding, ask a health professional before use.

    Keep out of the reach of children. In case of overdose, contact a physician or poison control center immediately.

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  • Directions

    • do not use more than directed

    Adults and children: (12 years and older): Take 1 to 2 capsules every 4 to 6 hours as needed. Do not take more than 12 capsules in 24 hours.

    Children under 12 years: Do not give to children under 12 years of age.

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  • Other information

    • store at room temperature 59º-86ºF (15º-30ºC)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
    Close
  • Inactive ingredients

    D&C Red #28, FD&C Blue #1, FD&C Red #40, gelatin, starch

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  • Questions or comments? 1-800-634-7680
  • 182R Medique Diphen Label

    Collect Medi-Bucks

    See inside flap for more details

    Medique®

    Diphen

    Diphenhydramine HCl 25 mg

    Hay Fever/Allergies

    Fiebre del Heno/Alergias

    Pull to Open

    TiraParaAbrir

    Easy To Swallow Capsules

    Capsulas Faciles de Tragar

    200 Capsules

    (200 x 1)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Untarias

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  • ACTIVE INGREDIENT

    Active ingredient
    (in each tablet)

    Ibuprofen (NSAID*) 200 mg

    *nonsteroidal anti-inflammatory drug

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  • PURPOSE

    Purpose

    Pain reliever/fever reducer

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  • INDICATIONS & USAGE

    Uses

    Temporarily relieves minor aches and pains associated with

    headache
    backache
    common cold
    minor arthritis pain
    toothache
    menstrual cramps
    muscular aches

    Temporarily reduces fever.

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  • WARNINGS

    Warnings

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  • SPL UNCLASSIFIED SECTION

    Allergy alert: Ibuprofen may cause a severe allergic reaction which may include:

    • hives
    • asthma (wheezing)
    • rash
    • blisters
    • skin reddening
    • facial swelling
    • shock

    If an allergic reaction occurs, stop use and seek medical help right away.

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  • SPL UNCLASSIFIED SECTION

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • take a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed
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  • DO NOT USE

    Do not use

    • if you have ever had an allergic reaction to any other pain reliever/fever reducer
    • right before or after heart surgery
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  • ASK DOCTOR

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
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  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are

    • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
    • taking any other drug
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  • WHEN USING

    When using this product

    • take with food or milk if stomach upset occurs
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  • STOP USE

    Stop use and ask a doctor if

    • you experience any of the following signs of stomach bleeding:
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
      • pain gets worse or lasts for more than 10 days
      • fever gets worse or lasts for more than 3 days
      • redness or swelling is present in the painful area
    • any new or unexpected symptoms occur
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  • PREGNANCY OR BREAST FEEDING

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

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  • 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 right away.

    Close
  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed
    • the smallest effective dose should be used
    • do not take longer than 10 days, unless directed by a doctor (see Warnings)
    Close
  • SPL UNCLASSIFIED SECTION

    Adults and children: (12 years and older)

    Take 1 tablet every 4 to 6 hours while symptoms persist. If pain or fever does not respond to 1 tablet, 2 tablets may be used. Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

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  • SPL UNCLASSIFIED SECTION

    Children under 12 years:

    Do not give to children under 12 years of age.

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  • SPL UNCLASSIFIED SECTION

    Other information

    • read all product information before using
    • store at 68-77°F (20-25°C)
    • avoid excessive heat 40°C (above 104°F)
    • tamper evident sealed packets
    • do not use any opened or torn packets
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  • INACTIVE INGREDIENT

    Inactive ingredients

    carnauba wax*, cellulose*, colloidal silicon dioxide, corn starch*, hypromellose, iron oxide red*, lactose, magnesium stearate, microcrystalline cellulose*, polydextrose, polyethylene glycol, povidone, silica*, sodium lauryl sulfate*, sodium starch glycolate, stearic acid*, titanium dioxide, triacetin*

    *may contain

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  • QUESTIONS

    Questions or comments? 1-800-634-7680

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  • Principal Display Panel

    Medi-First®
    Ibuprofen 200 mg
    Pain Reliever/Fever Reducer (NSAID)
    Easy To Swallow Film Coated Tablets
    See new warnings information
    100 tablets (50 x 2)
    Compare active ingredient to: Genuine Advil®
    Registered trademark Wyeth Consumer
    Tamper Evident Unit Dose Packets

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  • Active ingredient (in each tablet)

    Acetaminophen 325 mg

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  • Purpose

    Pain reliever/fever reducer

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  • Uses

    For the temporary relief of minor aches and pains associated with

    • headache
    • common cold
    • muscular aches
    • toothache
    • minor arthritis pain
    • menstrual cramps

    For the reduction of fever.

    Close
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

    • more than 12 tablets in 24 hours, which is the maximum daily amount
    • with other drugs containing acetaminophen
    • 3 or more alcoholic drinks every day while using this product

    Do not use

    • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    • for more than 10 days for pain unless directed by a doctor
    • for more than 3 days for fever unless directed by a doctor

    Ask a doctor before use if you have

    • liver disease

    Ask a doctor or pharmacist before use if

    • you are taking the blood thinning drug warfarin

    Stop using and ask a doctor if

    • symptoms do not improve
    • new symptoms occur
    • pain or fever persists or gets worse
    • redness or swelling is present

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

    If pregnant or breast-feeding, ask a health professional before use.

    Close
  • Directions

    • do not use more than directed

    Adults and children: (12 years and older)

    Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

    Children under 12 years:

    Do not give to children under 12 years of age.

    Other information

    • store at room temperature 59°-86°F (15°-30°C)
    • tamper-evident sealed packets
    • do not use any opened or torn packets
    Close
  • Inactive ingredients

    corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone, pregelatinized starch*, sodium starch glycolate, stearic acid

    * may contain

    Close
  • Questions or comments? 1-800-634-7680
  • Principal Display Panel
  • 145R Medique APAP 325 mg Label

    Collect MediBucks

    See inside flap for more details

    Medique®

    APAP

    Acetaminophen 325 mg

    Pain Reliever/Fever Reducer

    Alivia el Dolor/Reduce la Fiebre

    Easy To Swallow

    Film Coated Tablets

    Facil de Tragar Tabletas con Cubierta Pelicular

    Pull to Open

    Tire Para Abrir

    See new warnings information

    500 Tablets

    (250 x 2)

    Tamper Evident Unit Dose Packets

    Empaquetado con Sellado Evidente en Dosis Unitarias

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  • Weekender Kit Label

    Mountain Series Medical Kit Weekender

    Adventure Medical Kits BE SAFE

    1-6 People up to 7 days

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  • ACTIVE INGREDIENT

    Povidone-iodine 10%

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  • PURPOSE

    Antiseptic

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  • WARNINGS AND PRECAUTIONS

    Warnings

                Do not use

    • if allergic to iodine
    • in the eyes

                For external use only

                Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

                Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

                Avoid pooling beneath patient

                Keep out of reach of children.  In case of accidental ingestion, seek professionalassistance or consult a poison control center immediately.


    Close
  • INGREDIENTS AND APPEARANCE
    MOUNTAIN SERIES WEEKENDER MEDICAL 
    benzalkonium chloride, povidone-iodine, acetaminophen, aspirin, diphenhydramine hydrochloride, ibuprofen, bacitracin zinc, neomycin sulfate, polymyxin b sulfate kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:44224-0118
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:44224-0118-1 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 6 PACKAGE 4.8 mL
    Part 2 3 TUBE 1.5 g
    Part 3 2 PACKET
    Part 4 2 PACKET
    Part 5 1 PACKET
    Part 6 2 PACKET
    Part 7 1 PACKET 22 g
    Part 1 of 7
    ANTISEPTIC TOWELETTE 
    benzalkonium chloride swab
    Product Information
    Item Code (Source) NDC:52124-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0001-1 0.8 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 04/23/2010
    Part 2 of 7
    GENUINE TRIPLE ANTIBIOTIC 
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source) NDC:52124-0003
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52124-0003-1 0.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 02/16/2010
    Part 3 of 7
    MEDIQUE ASPIRIN 
    aspirin tablet, film coated
    Product Information
    Item Code (Source) NDC:47682-116
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code 44;157;aspirin
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-116-99 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part343 12/30/2008
    Part 4 of 7
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride capsule
    Product Information
    Item Code (Source) NDC:47682-182
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Color pink (pink) , white (white) Score no score
    Shape CAPSULE (CAPSULE) Size 14mm
    Flavor Imprint Code CPC;835
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-182-46 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part341 12/30/2008
    Part 5 of 7
    MEDI-FIRST IBUPROFEN 
    ibuprofen tablet, film coated
    Product Information
    Item Code (Source) NDC:47682-808
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code 44;352
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-808-99 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA075139 12/30/2008
    Part 6 of 7
    MEDIQUE APAP 
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source) NDC:47682-145
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    Color white (white) Score no score
    Shape ROUND (ROUND) Size 10mm
    Flavor Imprint Code AZ;234
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:47682-145-99 2 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part343 12/30/2008
    Part 7 of 7
    APLICARE POVIDONE-IODINE SOLUTION 
    povidone-iodine solution solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 9.8 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22 g in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333A 08/01/2011
    Labeler - Tender Corporation dba Adventure Medical Kits (064437304)
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