Indications and uses
For skin surface sanitizing to decrease bacteria.
Antibacterial Wipes
- Manufacturer
- Fitguard
- Effective date
- 2022-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:52:38
Label at a glance#
ProductAntibacterial Wipes
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 sections
Dosage and administration
Important! Do not open the top of the bag. 1. Cut a 1" opening into the top center of the bag along dashed line. 2. Pull out the center wipe from the bag through the 1" hole. 3. Place the bag of wipes into the dispenser. 4. Thread the center wipe through the hole in the top of the dispenser.
Label contents#
Full prescribing information#
Purpose
Antibacterial
Active Ingredient:
Benzalkonium Chloride 0.30%
Inactive Ingredients:
Water, Phenoxyethanol, DMDM Hydantoin, Polysorbate 20, Ethylparaben, Methylparaben, Fragrance, Disodium EDTA, Sodium Citrate, Cetylpyridinium Chloride
Uses:
For skin surface sanitizing to decrease bacteria.
Warnings:
For external use only.
May irritate eyes.
Keep out of reach of children unless under adult supervision.
Warnings:
Keep out of reach of children unless under adult supervision.
Directions:
Important! Do not open the top of the bag.
1. Cut a 1" opening into the top center of the bag along dashed line.
2. Pull out the center wipe from the bag through the 1" hole.
3. Place the bag of wipes into the dispenser.
4. Thread the center wipe through the hole in the top of the dispenser.
Instructions for use:
Take single sheets as needed and apply topically to clean skin.
Fitguard Antibacterial Wipes, 800 Count
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 78494-003-04 | 2024-01-30 | C162847 | 48780-1 | d6a99b39-7cdc-a426-e053-dadaa90af4c2 | Fitguard Antibacterial Hand Wipes |
| 78494-001-01 | 2022-02-25 | C162847 | 48780-1 | d6a99b39-7cdc-a426-e053-dadaa90af4c2 | Fitguard Antibacterial Hand Wipes |
| 78494-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-7cdc-a426-e053-dadaa90af4c2 | Fitguard Antibacterial Hand Wipes |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78494-003-04 | Antibacterial Wipes | 1 in 1 BAG | CLOTH | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Antibacterial Wipes
- Benzalkonium Chloride
- BENZALKONIUM
- SODIUM CITRATE
- DMDM HYDANTOIN
- ETHYLPARABEN
- METHYLPARABEN
- WATER
- PHENOXYETHANOL
- DISODIUM EDTA-COPPER
- POLYSORBATE 20
- ALOE VERA LEAF
- FRAGRANCE 13576
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 78494-003 | 78494-003-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| DMDM HYDANTOIN | BYR0546TOW | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| DISODIUM EDTA-COPPER | 6V475AX06U | IACT |
| POLYSORBATE 20 | 7T1F30V5YH | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| FRAGRANCE 13576 | 5EM498GW35 | IACT |
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 |
|---|---|---|---|---|---|---|
| ef6ea8b2-a7f4-857f-e053-2a95a90a1136 | a798cd55-e0e6-328d-e053-2a95a90a3d69 | 2022-12-09 | Warnings | ef6ea8b2-a7f4-857f-e053-2a95a90a1136 a798cd55-e0e6-328d-e053-2a95a90a3d69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.