Adventure Medical Kits 1-4 Person [2.0] First Aid Kit

Adventure Medical Kits 1-4 Person [2.0] First Aid Kit
SPL v9
SPL
SPL Set ID 9fcaff71-ca36-4f96-b252-a73607de19f9
Routes
TOPICAL ORAL
Published
Effective Date 2010-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU]) Benzocaine (6 mL) Alcohol (60 mL) Ibuprofen (200 mg) Diphenhydramine (25 mg) Acetaminophen (500 mg) Aspirin (325 mg) Benzalkonium (0.40 mL)
Inactive Ingredients
Water Powdered Cellulose Starch, Corn Hypromelloses Lactose Magnesium Stearate Polydextrose Polyethylene Glycol Povidone Silicon Dioxide Stearic Acid Titanium Dioxide Triacetin Gelatin D&c Red No. 28 Fd&c Blue No. 1 Fd&c Red No. 40 Crospovidone Hydroxypropyl Cellulose Cellulose, Microcrystalline Mineral Oil Propylene Glycol Carboxymethylcellulose Sodium Talc

Identifiers & Packaging

Pill Appearance
Imprint: 44;157;ASPIRIN Shape: round Shape: capsule Color: white Color: pink Size: 10 mm Size: 14 mm Size: 12 mm Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-26

Description

Active Ingredient: .........Bacitracin Zinc 400 units Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base) Polymyxin B Sulfate 5000 units


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses   for the temporary relief of minor aches and pains associated with

headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

Dosage and 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.



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.



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



Description

Made in CHINA

LOT/EXP:

Section 44425-7

Other information:

Store at room temperature.

Section 50565-1

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

Section 50566-9

Stop use and consult a doctor:

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

Section 50567-7

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

Section 50568-5


Ask a doctor before use if you are:

taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

Section 50569-3
Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Section 50570-1

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.

Section 51727-6

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Section 51945-4

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.

Section 53414-9
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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1

Uses:  To help prevent infection in:

minor cuts;  scrapes;  burns

Section 55106-9

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

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

Polymyxin B Sulfate 5000 units


Structured Label Content

Indications and Usage (34067-9)

Uses   for the temporary relief of minor aches and pains associated with

headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

Dosage and Administration (34068-7)
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.



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.



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



Warnings and Precautions (34071-1)

Warnings:

For external use only.

Description (34089-3)

Made in CHINA

LOT/EXP:

Section 44425-7 (44425-7)

Other information:

Store at room temperature.

Section 50565-1 (50565-1)

Keep out of reach of children.

If ingested, contact a Poison

Control Center right away.

Section 50566-9 (50566-9)

Stop use and consult a doctor:

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

Section 50567-7 (50567-7)

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

Section 50568-5 (50568-5)


Ask a doctor before use if you are:

taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug

Section 50569-3 (50569-3)
Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

Section 51945-4 (51945-4)

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.

Section 53414-9 (53414-9)
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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Section 55105-1 (55105-1)

Uses:  To help prevent infection in:

minor cuts;  scrapes;  burns

Section 55106-9 (55106-9)

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

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

Polymyxin B Sulfate 5000 units


Advanced Ingredient Data


Raw Label Data

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