Dosage and administration
• 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.
Refill 2
- Manufacturer
- GFA Production (Xiamen) Co., Ltd.
- Effective date
- 2024-10-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:51:01
Label at a glance#
ProductRefill 2
Active ingredientBENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure14 sections
Label contents#
Full prescribing information#
Active ingredients (in each gram)
Bacitracin zinc (bacitracin 400 units)
Neomycin sulfate (neomycin 3.5mg)
Polymyxin B sulfate (polymyxin B 5,000 units)
Purpose
First aid antibiotic
Use
- First aid to help prevent infection in minor cuts, scrapes, and burns.
Warnings
For external use only.
Do not use
• 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
• deep or punture wounds • animal bites • serious burns.
Stop use and ask a doctor if
• the condition persists or gets worse • a rash or other allergic reaction develops.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• 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
Store at room temperature
Inactive ingredients
Mineral oil, petrolatum, purified water
Active Ingredient:
Benzalkonium Chloride 0.13%
Purpose
First Aid Antiseptic
Use:
For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.
Warnings
For external use only.
Keep out of reach of children.
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:
In the eyes, or over large areas of the body.
Directions:
Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.
Inactive ingredient:
Purified water.
Antibiotic Application (50814-013-01) Labeling:
Antiseptic Towelettes (50814-011-01) Labeling:
Refill 2 (50814-016-01) Labeling:
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50814-011 | REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.] | 5 | Unmatched | 20241030_b479c3e9-cccc-4734-87cd-4d7dfc00ca1d.zip |
| 50814-013 | REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.] | 5 | Unmatched | 20241030_b479c3e9-cccc-4734-87cd-4d7dfc00ca1d.zip |
| 50814-016 | REFILL 2 (BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.] | 5 | Legacy NDC | 20241030_b479c3e9-cccc-4734-87cd-4d7dfc00ca1d.zip |
Products#
Every source-derived product name is available through these pages.
- Refill 2
- BENZALKONIUM CHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
- Antiseptic Towelettes
- BENZALKONIUM CHLORIDE
- WATER
- BENZALKONIUM
- Antibiotic Application
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
- MINERAL OIL
- PETROLATUM
- BACITRACIN ZINC
- BACITRACIN
- NEOMYCIN SULFATE
- NEOMYCIN
- POLYMYXIN B SULFATE
- POLYMYXIN B
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50814-016 | 50814-016-01 |
| 50814-011 | 50814-011-01 |
| 50814-013 | 50814-013-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| WATER | 059QF0KO0R | IACT |
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
| NEOMYCIN SULFATE | 057Y626693 | ACTIM |
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 2407b7dc-d419-4ff0-e063-6394a90a7cf3 | b479c3e9-cccc-4734-87cd-4d7dfc00ca1d | 2024-10-09 | Warnings | 2407b7dc-d419-4ff0-e063-6394a90a7cf3 b479c3e9-cccc-4734-87cd-4d7dfc00ca1d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.