standard ansi first aid kit

standard ansi first aid kit
SPL v13
SPL
SPL Set ID e1ef74bf-8895-4200-a411-f726dcdaa945
Routes
ophthalmic topical
Published
Effective Date 2016-08-10
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 2016-08-10

Purpose

First Aid Antiseptic

Description

Purified Water 99.1%


Medication Information

Warnings

For external use only.

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

Directions

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

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)

Inactive Ingredients

Benzalkonium chloride, sodium chloride

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.

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.

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%

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.

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:

Alcohol Cleansing Pads (49687 0012 0) Labeling:

Antibiotic Application (49687 0013 0) Labeling:

Antiseptic Towelettes (49687 0016 0) Labeling:

Standard Ansi First Aid (49687 0020 0) Labeling:


Structured Label Content

Warnings

For external use only.

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

Directions

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

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)

Inactive Ingredients (Inactive ingredients)

Benzalkonium chloride, sodium chloride

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.

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.

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%

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.

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:)

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:)

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

Standard Ansi First Aid (49687 0020 0) Labeling: (Standard ANSI First Aid (49687-0020-0) Labeling:)


Advanced Ingredient Data


Raw Label Data

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