Gfa First Aid Kit

Gfa First Aid Kit
SPL v3
SPL
SPL Set ID fa23be25-61c3-491c-b9e6-a5275c9bdc13
Routes
TOPICAL OPHTHALMIC ORAL
Published
Effective Date 2011-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.4 mL) Lidocaine (0.13 g) Bacitracin (0.5 g) Neomycin (400 [iU]) Polymyxin B (5 mg) Iodine (5000 [iU]) Water (1 mL) Alcohol (98.16 mL) Isopropyl Alcohol (62 g) Benzocaine (70 mL) Ibuprofen (6 mL) Acetaminophen (60 mL) Aspirin (200 mg)
Inactive Ingredients
Water Aloe Vera Leaf Cetyl Alcohol Diazolidinyl Urea Edetate Disodium Glycerin Glyceryl Monostearate Methylparaben Mineral Oil Polyethylene Glycol Propylene Glycol Propylparaben Stearic Acid Sodium Chloride Sodium Phosphate, Monobasic Sodium Phosphate, Dibasic Benzalkonium Chloride Titanium Dioxide Powdered Cellulose Starch, Corn Hypromelloses Lactose Magnesium Stearate Polydextrose Povidone Silicon Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 44;157;ASPIRIN Shape: round Color: white Size: 10 mm Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-05-03

Description

Active Ingredient:                         Benzalkonium Chloride 0.40%

Purpose

Antiseptic


Medication Information

Warnings and Precautions

Warning:

If you experience eye pain, changes in vision, continued redness or irritation of the eye,

or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Do not use if solution changes color or becomes cloudy.

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

LOT/EXP:                                    Made in CHINA



20130301





GFA Production Xiamen Co., Ltd

No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100

Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

Use

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

Uses

Provides, antiseptic germicidal skin preperation for minor invasive procedures

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

Other information:

Store at room temperature.

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  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 the eyes or over large areas of the body.

Section 51727-6

Inactive Ingredients:

Sodium Chloride USP                                          44mg

Monobasic Sodium Phosphate USP                18mg

Sodium Phosphate Dibasic USP                       111mg 



Edetate Disodium USP                                       10mg



Benzalkonium Chloride                                      0.5mg

NF (as preservative)





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. 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:



For flushing or irrigating the eyes to



remove loose foreign material, air pollutants,



or chlorinated water.

Section 55106-9

Active Ingredient:

Purified Water USP...q.s.

Caution

In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.

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.



Do Not Use

in the eyes. In case of contact, rinse eyes thoroughly with water.

Active Ingredient

Active Ingredient:                        

Benzalkonium Chloride 0.40%

Other Information
Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

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



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 get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

Keep Out of Reach of Children

For external use only.

Stop Use and Consult A Doctor


if irritation and redness develop and persist for more than 72 hours

Active Ingredient (in Each Tablet)

Ibuprofen USP (NSAID*) 200mg

*nonsteroidal anti-inflammatory drug

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


Structured Label Content

Use

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

Uses

Provides, antiseptic germicidal skin preperation for minor invasive procedures

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)

Warning:

If you experience eye pain, changes in vision, continued redness or irritation of the eye,

or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Do not use if solution changes color or becomes cloudy.

Section 34072-9 (34072-9)

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

Description (34089-3)

LOT/EXP:                                    Made in CHINA



20130301





GFA Production Xiamen Co., Ltd

No. 20 Huli Industrial Park, Meixi Road, Tong'an, Xiamen, Fujian, China 361100

Tel: 86-592-7269515 Fax: 86-592-7269528 Http: //www.gfaproduction.com

Section 42229-5 (42229-5)

LOT/EXP:                           Made in CHINA

20130301

Section 44425-7 (44425-7)

Other information:

Store at room temperature.

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  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 the eyes or over large areas of the body.

Section 51727-6 (51727-6)

Inactive Ingredients:

Sodium Chloride USP                                          44mg

Monobasic Sodium Phosphate USP                18mg

Sodium Phosphate Dibasic USP                       111mg 



Edetate Disodium USP                                       10mg



Benzalkonium Chloride                                      0.5mg

NF (as preservative)





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. 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:



For flushing or irrigating the eyes to



remove loose foreign material, air pollutants,



or chlorinated water.

Section 55106-9 (55106-9)

Active Ingredient:

Purified Water USP...q.s.

Caution

In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swelling or infection occurs, discontinue use and contact a physician.

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.



Do Not Use (Do not use)

in the eyes. In case of contact, rinse eyes thoroughly with water.

Active Ingredient

Active Ingredient:                        

Benzalkonium Chloride 0.40%

Other Information (Other information)
Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets

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



When Using This Product (When using this product)
take with food or milk if stomach upset occurs

Stop Use and Ask A Doctor If (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 get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear

Keep Out of Reach of Children (Keep out of reach of children)

For external use only.

Stop Use and Consult A Doctor (Stop use and consult a doctor)


if irritation and redness develop and persist for more than 72 hours

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Ibuprofen USP (NSAID*) 200mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Before Use If You Are: (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


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