Easy Care First Aid Kit Sports And Travel

Easy Care First Aid Kit Sports And Travel
SPL v1
SPL
SPL Set ID c66d2fe6-8ea3-43ac-b6eb-b069641e781c
Routes
TOPICAL ORAL
Published
Effective Date 2011-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.4 mL) Benzocaine (6 mL) Alcohol (60 mL) Bacitracin (400 [iU]) Neomycin (5 mg) Polymyxin B (5000 [iU]) Acetaminophen (325 mg) Ibuprofen (200 mg)
Inactive Ingredients
Water Starch, Corn Polyethylene Glycol Stearic Acid Povidone Powdered Cellulose Hypromelloses Lactose Magnesium Stearate Polydextrose Silicon Dioxide Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;352 Shape: round Color: white Size: 11 mm Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-04-13

Description

Active Ingredient:                         Benzalkonium Chloride 0.40%

Purpose

Antiseptic


Medication Information

Warnings and Precautions

Warnings: For external use only.

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

Indications and Usage

Uses:  To help prevent infection in:

minor cuts;  scrapes;  burns

Purpose


Antiseptic

Dosage and Administration

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.

Description

Made in CHINA

LOT/EXP:

Use

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

Section 34072-9

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

Section 42229-5

LOT/EXP:                           Made in CHINA

20130301

Section 44425-7

Flammable - keep away from fire or flame.

Section 50565-1

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

Section 50566-9

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

Section 50567-7
When using this product:

take with food or milk if stomach upset occurs

Section 50568-5

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

Section 50569-3

Ask a doctor before use if the user has liver disease

Section 50570-1

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

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

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Section 53414-9

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

Section 55105-1

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

Section 55106-9

Active Ingredient:                           Purpose:

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

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

Warnings

Warning:   For external use only.

Directions

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



Active Ingredient

Active Ingredient:                        

Benzalkonium Chloride 0.40%

Active Ingredients

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

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

Polymyxin B Sulfate 5000 units

Inactive Ingredient
water
Inactive Ingredients

Inactive Ingredient:   Purified water




Structured Label Content

Use

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

Indications and Usage (34067-9)

Uses:  To help prevent infection in:

minor cuts;  scrapes;  burns

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings: For external use only.

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

Section 34072-9 (34072-9)

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

Description (34089-3)

Made in CHINA

LOT/EXP:

Section 42229-5 (42229-5)

LOT/EXP:                           Made in CHINA

20130301

Section 44425-7 (44425-7)

Flammable - keep away from fire or flame.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)
When using this product:

take with food or milk if stomach upset occurs

Section 50568-5 (50568-5)

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

Section 50569-3 (50569-3)

Ask a doctor before use if the user has liver disease

Section 50570-1 (50570-1)

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

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)

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Active Ingredient:                           Purpose:

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

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

Purpose


Antiseptic

Warnings

Warning:   For external use only.

Directions

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



Active Ingredient

Active Ingredient:                        

Benzalkonium Chloride 0.40%

Active Ingredients

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

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

Polymyxin B Sulfate 5000 units

Inactive Ingredient
water
Inactive Ingredients

Inactive Ingredient:   Purified water




Advanced Ingredient Data


Raw Label Data

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