Large Ansi First Aid Kit

Large Ansi First Aid Kit
SPL v15
SPL
SPL Set ID fa8578c2-a0bc-4e2e-a4f9-d48debfff378
Routes
OPHTHALMIC TOPICAL
Published
Effective Date 2016-08-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Water (991 mg) Benzalkonium (0.13 g) Isopropyl Alcohol (70 g) Bacitracin (400 [iU]) Neomycin (3.5 mg) Polymyxin B (5000 [iU]) Alcohol (0.5 g)
Inactive Ingredients
Benzalkonium Chloride Sodium Chloride Water Mineral Oil Petrolatum Glycerin Carboxypolymethylene Propylene Glycol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-08-09

Description

Purified Water 99.1%

Purpose

First Aid Antiseptic


Medication Information

Purpose

Eyewash

Description

Purified Water 99.1%

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

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 in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Purpose:

First Aid Antiseptic

Stop Use

if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Warnings

For external use only.

Warnings:

For external use only.

Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Do Not Use

if solution changes color or becomes cloudy

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, or over large areas of the body.

Active Ingredient

Purified Water 99.1%

Other Information

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Active Ingredient:

Benzalkonium Chloride 0.13%

Active Ingredients

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%

Other Information:

Store at room temperature 15°-30° C (59°-86° F)

Inactive Ingredient:

Purified water.

Inactive Ingredients

Benzalkonium chloride, sodium chloride

When Using This Product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Keep Out of Reach Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep Out of Reah of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram)

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)



Eye Wash (49687 0010 0) Labeling:

Ask A Doctor Before Use If You Have

• deep or punture wounds • animal bites • serious burns.

Burn Treatment (49687 0014 0) Labeling:

Hand Sanitizer (49687 0015 0) Labeling:

Antiseptic Towelettes (49687 0016 0) Labeling:

Alcohol Cleansing Pads (49687 0012 0) Labeling:

Antibiotic Application (49687 0013 0) Labeling:

Large Ansi First Aid Kit (49687 0021 0) Labeling:


Structured Label Content

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

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 in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns , minor cuts, and scrapes
Purpose

Eyewash

Purpose:

First Aid Antiseptic

Stop Use (Stop use)

if irritation and redness develop. If condition persists for more than 72 hours, consult your doctor.

Warnings

For external use only.

Warnings:

For external use only.

Directions

• Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Do Not Use (Do not use)

if solution changes color or becomes cloudy

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, or over large areas of the body.

Active Ingredient (Active ingredient)

Purified Water 99.1%

Other Information (Other information)

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Active Ingredient:

Benzalkonium Chloride 0.13%

Active Ingredients (Active ingredients)

Benzalkonium chloride 0.13% Lidocaine hydrochloride 0.5%

Other Information: (Other information:)

Store at room temperature 15°-30° C (59°-86° F)

Inactive Ingredient: (Inactive ingredient:)

Purified water.

Inactive Ingredients (Inactive ingredients)

Benzalkonium chloride, sodium chloride

When Using This Product (When using this product)

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

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

If swallowed, get medical help or contact a Poison Control Center right away.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

• you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep Out of Reah of Children. (Keep out of reah of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Gram) (Active ingredients (in each gram))

Bacitracin zinc (bacitracin 400 units) Neomycin sulfate (neomycin 3.5mg) Polymyxin B sulfate (polymyxin B 5,000 units)



Eye Wash (49687 0010 0) Labeling: (Eye Wash (49687-0010-0) Labeling:)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• deep or punture wounds • animal bites • serious burns.

Burn Treatment (49687 0014 0) Labeling: (Burn Treatment (49687-0014-0) Labeling:)

Hand Sanitizer (49687 0015 0) Labeling: (Hand Sanitizer (49687-0015-0) Labeling:)

Antiseptic Towelettes (49687 0016 0) Labeling: (Antiseptic Towelettes (49687-0016-0) Labeling:)

Alcohol Cleansing Pads (49687 0012 0) Labeling: (Alcohol Cleansing Pads (49687-0012-0) Labeling:)

Antibiotic Application (49687 0013 0) Labeling: (Antibiotic Application (49687-0013-0) Labeling:)

Large Ansi First Aid Kit (49687 0021 0) Labeling: (Large ANSI First Aid Kit (49687-0021-0) Labeling:)


Advanced Ingredient Data


Raw Label Data

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