Easy Care First Aid Kit Sports And Travel

Easy Care First Aid Kit Sports And Travel
SPL v1
SPL
SPL Set ID f993a178-78a6-410d-b480-b7dbe3639b05
Routes
TOPICAL ORAL
Published
Effective Date 2011-04-15
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) Lidocaine (0.13 g)
Inactive Ingredients
Water Starch, Corn Polyethylene Glycol Stearic Acid Povidone Powdered Cellulose Hypromelloses Lactose Magnesium Stearate Polydextrose Silicon Dioxide Titanium Dioxide Triacetin Aloe Vera Leaf Cetyl Alcohol Diazolidinyl Urea Edetate Disodium Glycerin Glyceryl Monostearate Methylparaben Mineral Oil Propylene Glycol Propylparaben

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 2011-04-15

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.

Uses

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

Minor Cuts

Scrapes

Burns

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.

Uses

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

Minor Cuts

Scrapes

Burns

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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