Label: CVS HEALTH MEDICATION AND TOPICAL REFILL POUCH- aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen kit

  • NDC Code(s): 44224-0001-2, 52124-0001-1, 52124-0003-1, 52124-0014-1, view more
    52124-0015-1, 52124-0016-1, 52124-0017-1, 69842-404-00
  • Packager: CVS
  • 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 January 18, 2017

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

  • Active Ingredients - Genuine Triple Antibiotic

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

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

    Polymyxin B Sulfate 5000 units

  • Purpose - Genuine Triple Antibiotic

    Triple Antibiotic

  • Uses - Genuine Triple Antibiotic

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

  • Warnings - Genuine Triple Antibiotic

    For external use only

  • DO NOT USE - Genuine Triple Antibiotic

    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 - Genuine Triple Antibiotic

    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 - Genuine Triple Antibiotic

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

  • Directions - Genuine Triple Antibiotic

    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 - Genuine Triple Antibiotic

    Other information:

    Store at room temperature.

  • Inactive Ingredients - Genuine Triple Antibiotic

    Vaseline
    Mineral Oil
    Purified Water

  • Active Ingredients - Antiseptic

    Active Ingredient:

    Benzalkonium Chloride 0.13

  • Purpose - Antiseptic

    Antiseptic

  • Use - Antiseptic

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

  • Warnings - Antiseptic

    Warning: For external use only.

  • Keep out of reach of children - Antiseptic

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

  • Stop Use - Antiseptic

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

  • Do Not Use - Antiseptic

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

  • Directions - Antiseptic

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

  • Inactive Ingredients - Antiseptic

    Inactive Ingredient: Purified water

  • Active Ingredients - Non-Aspirin

    Acetaminophen 500 mg

  • Purpose - Non Aspirin

    Analgesic/antipyretic

  • Uses - Non Aspirin

    temporary relief of minor aches and pains associated with:

    common cold; headache; toothache; muscular aches; backache; arthritis; menstrual cramps; and reduction of fever

  • Warnings - Non Aspirin

    Liver warning: This product contains acetaminophen.

    Severe liver damage may occur if: adult takes more than 12 tablets in 24 hours, which is the maximum daily amount; child takes more than 5 doses in 24 hours; taken with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product

  • Do Not Use - Non Aspirin

    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 - Non Aspirin

    Ask a doctor before use if the user has liver disease

    Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

  • Stop Use - Non Aspirin

    Stop use and ask a doctor if: symptoms do not improve; pain gets worse or lasts for more than 10 days; fever gets worse or lasts for more than 3 days; new symptoms occur; redness or swelling is present; a rare sensitivity reaction occurs

  • Pregnancy - Non Aspirin

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

  • Keep Out of Reach of Children - Non Aspirin

    Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt
    medical attention is critical for adults as well as for children even if
    you do not notice any signs or symptoms. Do not exceed recommended dosage

  • Inactive Ingredients - Non Aspirin

    Cornstarch, polyethylene glycol, stearic acid, povidone

  • Directions - Non Aspirin

    Directions

    Adults and Children Take 2 tablets every 4 to 6 hours as

    12 years of age needed. Do not take more than 12 tablets

    or older in 24 hours.

    Children 6-11 years Take 1 tablet every 4 to 6 hours as

    of age needed. Do not take more than 5

    tablets in 24 hours.

    Children under 6 Do not use this regular strength product.

    years of age This will provide more than the

    recommended dose (overdose) and could

    cause serious health problems.

  • Storage and Handling - Non Aspirin

    Store at 59-86 degree F (15-30 degree C)

    tamper evident sealed packets; do not use any open or torn packets

  • Active Ingredients - After Bite

    Active Ingredient:

    Ammonia 3.5%

  • Purpose - After Bite

    Counterirritant

  • Uses - After Bite

    Temporarily protects and helps relieve minor skin irriatation and itching due to

    • insect bites and stings
    • poison ivy, oak or sumac
  • Warnings - After Bite

    Warning: For external use only.

  • Keep Out of Reach of Children - After Bite

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

  • Stop Use - After Bite

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
  • When Using - After Bite

    Do not get into eyes

  • DIrections - After Bite

    Adults and children under 2 years and older dab directly on bite or sting, rub gently and re-apply as needed

    Children under 2 years ask a doctor

  • Active Ingredient - Aspirin

    Aspirin (NSAID*) 325mg

    *nonsteroidal anti-inflammatory drug

  • Purpose

    Pain Releiver / Fever Reducer

  • Uses - Aspirin

    Temporarily relieves minor aches and pains associated with: headache; muscular aches; minor arthritis pain; backache; common cold; toothache; mentrual cramps; temporarily reduces fever

  • Warnings

    Reye's syndrome: Children and teenagers who have or are recovering from chicken pox of 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.

    Allergy Alert: Aspirin may cause a severe allergic reaction which may include: hives, skin reddening, facial swelling, rash, asthma (wheezing), blisters, shock. If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This contains an NSAID, which may cause severe stomach bleeding. The change is higher if you: are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks everyday while using this product, take more for a longer time than directed

  • Do Not Use - Aspirin

    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 a prescription drug 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 - Aspirin

    Stop Use and ask a Doctor if:

    You experience any of the following signs of stomach bleeding, you 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 painful areas, or 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 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.

  • Directions - Aspirin

    Do not use more than directed - the smallest effective dose should be used.

    Drink a full glass of water with each dose.

    Do not take longer than 10 days, unless directed by a doctor.

    Adults and Children (12 years and older): take 1 or 2 tablets with water every 4 hours as needed. Do not take more then 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.

    Avoid excessive heat and humidity, do not use any open or torn packets.

  • Inactive Ingredients - Aspirin

    hypromellose, polyethylene glycol, propylene glycol, corn starc

  • Active Ingredient - Diphenhydramine

    Diphenhydramine Hydrochloride 25mg

  • Purpose - Diphenhydramine

    Antihistimine

  • Use - Diphenhydramine

    Temporarily relieves the following symptoms associated with hay fever or oother upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itchy, watery eyes

  • Warnings

    Ask a doctor before use if you have: a breathing problem such as emphyseme or chronic bronchitis, glaucoma, difficulty in urination due to enlargement of the prostate gland; or if you are: taking any drugs for asthma, sedatives or tranquilizers.

    When using this product: Drowziness may occur, avoid alcoholic beverages.

    Alcohol, sedatives and tranquilizers may increase the drowziness effect. Use caution when driving a motor vehicle or operating machinery. Excitality may occur, especially in children.

    Keep out of Reach of Children

    Do not exceed recommended dosage. Keep this and all drugs out of reach of children. In case of accidental overdose, contact a physician or poison control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using the product.

  • Dosage - Diphenhydramine

    Adults and Children (12 Years and older) - take 1 capsule every 4 to 6 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 unless directed by a doctor

  • Inactive Ingredients

    DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch

  • Active Ingredient - Alcohol Pad

    Isopropyl Alcohol 70%

  • Uses - Alcohol Prep Pad

    For preparation of the skin before injection

  • Warnings - Alcohol Prep Pad

    For External Use Only

    Flammable - Keep away from fire or flame

    Do Not Use - with electrocautery, in eyes

    Stop Use and Ask a Doctor if - Irritation or redness develop and 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 - Alcohol Prep Pad

    Tear Open packet, unfold and use as and wipe injection site vigorously and discard.

    Store at Room Temperature

  • Inactive Ingredients - Alcohol Pad

    Water

  • Packaging

    Medications and TopicalsAntisepticTriple AntibioticAspirinNon AspirinDiphenhydramineAlcohol Prep padAfter Bite Wiipe

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH MEDICATION AND TOPICAL REFILL POUCH 
    aspirin, diphenhydramine hydrochloride, aspirin, isopropyl alcohol, bacitracin zinc, neomycin sulfate, polymyxin b, acetaminophen kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-404
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-404-001 in 1 BAG; Type 0: Not a Combination Product12/28/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET
    Part 24 PACKAGE 3 mL  in .7 
    Part 34 PACKAGE 3 mL  in .7 
    Part 41 PACKAGE
    Part 515 PACKAGE 12 mL  in .8 
    Part 66 TUBE 3 g  in .5 
    Part 72 PACKET
    Part 1 of 7
    DIPHENHYDRAMINE 
    diphenhydramine hydrochloride capsule
    Product Information
    Item Code (Source)NDC:52124-0016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0016-12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/01/2016
    Part 2 of 7
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0017-10.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2017
    Part 3 of 7
    AFTER BITE WIPE 
    ammonia swab
    Product Information
    Item Code (Source)NDC:44224-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIA (UNII: 5138Q19F1X) (AMMONIA - UNII:5138Q19F1X) AMMONIA30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE 1000 (UNII: MCU2324216)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    C12-13 ALCOHOLS (UNII: T7ZJT3I9X2)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-0001-20.7 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/28/2016
    Part 4 of 7
    NON-ASPIRIN 
    acetaminophen tablet
    Product Information
    Item Code (Source)NDC:52124-0014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code AZ;234
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0014-12 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34312/28/2016
    Part 5 of 7
    ANTISEPTIC 
    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 CHLORIDE1.3 mg  in 1 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; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/28/2016
    Part 6 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) BACITRACIN400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-10.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/28/2016
    Part 7 of 7
    ASPIRIN 
    aspirin tablet
    Product Information
    Item Code (Source)NDC:52124-0015
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0015-12 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34312/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/28/2016
    Labeler - CVS (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tender Corporation064437304manufacture(69842-404)