Standard ANSI First Aid

Manufacturer
GFA Production (Xiamen) Co., Ltd.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:41:30

Label at a glance#

ProductStandard ANSI First Aid
Active ingredientWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE HYDROCHLORIDE, ALCOHOL
Label structure43 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified Water 99.1%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

• 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

• 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 INGREDIENT SECTION

Benzalkonium chloride, sodium chloride

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external use only.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

OTC - DO NOT USE SECTION

In the eyes, or over large areas of the body.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Purpose:

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

For preparation of the skin before injection.

Warnings:

WARNINGS SECTION

For external use only.

Flammable - keep away from fire or flame.

Do not use:

OTC - DO NOT USE SECTION

with electrocautery, in the eyes

Stop use

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard.

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Use

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition persists or gets worse • a rash or other allergic reaction develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Clean the affected area. • Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily. • May be covered with a sterile bandage.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral oil, petrolatum, purified water

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Pain relieving cream

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reah of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin monostearate, glycerol, purified water

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 62%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For handwashing to decrease bacteria on the skin
  • Recommended for repeated use.

Warnings

WARNINGS SECTION

Flammable, keep away from fire or flame

For external use only.

Do not use

OTC - DO NOT USE SECTION

in the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and allow to dry without wi

Other information

SPL UNCLASSIFIED SECTION

Store at 15° to 25°C (59° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbomer, propylene glycol, purified water, titanium dioxide

Eye Wash (50814-010-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Antiseptic Towelettes (50814-011-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

Alcohol Cleansing Pads (50814-012-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66

Antibiotic Application (50814-013-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

Burn Treatment (50814-014-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

77

Hand Sanitizer (50814-015-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

Standard ANSI First Aid (50814-020-01) Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

StandardStandard

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50814-020-012025-02-06C16284748780-12cef2736-5a11-d83d-e063-dadaa90ab31fStandard ANSI First Aid Kit
50814-020-012025-01-30C16284748780-12cef2736-5a11-d83d-e063-dadaa90ab31fStandard ANSI First Aid Kit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-010STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-011STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-012STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-013STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-014STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-015STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Unmatched20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip
50814-020STANDARD ANSI FIRST AID (WATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]9Legacy NDC20250209_94dd796a-d589-4744-b11a-acc8ef4b346f.zip

Products#

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NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 22 matching rows.

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Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0888b5f3-0432-f641-e063-6394a90a89c294dd796a-d589-4744-b11a-acc8ef4b346f2023-10-25WarningsExact identifier
spl id: 0888b5f3-0432-f641-e063-6394a90a89c2
spl set id: 94dd796a-d589-4744-b11a-acc8ef4b346f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.