Antiseptic Towelette

Antiseptic Towelette
SPL v1
SPL
SPL Set ID 58831c2e-ca33-469e-8b0f-ae2e88979877
Route
TOPICAL
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]) Lidocaine (0.13 g)
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

Identifiers & Packaging

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

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 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 50570-1

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

Section 51945-4

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

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

Warnings and Precautions (34071-1)

Warnings: For external use only.

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

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 50570-1 (50570-1)

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

Section 51945-4 (51945-4)

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

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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