OTC - ACTIVE INGREDIENT SECTION
BENZALKONIUM CHLORIDE;
PRAMOXINE HYDROCHLORIDE;
First Aid Antiseptic Pain Relieving
- Manufacturer
- Shandong Ruian Pharmaceutical Co.,Ltd.
- Effective date
- 2021-11-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:45:01
Label at a glance#
ProductFirst Aid Antiseptic Pain Relieving
Active ingredientBENZALKONIUM CHLORIDE, PRAMOXINE HYDROCHLORIDE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
First aid antibiotic
Topical analgesic
INDICATIONS & USAGE SECTION
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
• cuts
• scrapes
• burns
WARNINGS SECTION
For external use only
OTC - DO NOT USE SECTION
• in the eyes
• over large areas of the body
OTC - ASK DOCTOR SECTION
• deep or puncture wounds
• animal bites
• serious burns
OTC - STOP USE SECTION
• condition or symptoms get worse or last more than one week
• symptoms clear up and occur again within a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Centre right away.
DOSAGE & ADMINISTRATION SECTION
• Adults and children 2 years of age and older:
• Clean the affected area
• Spray a small amount of this product on the area 1 to 3 times daily.
• May be covered with a sterile bandage
• If bandaged, let dry first
• Children under 2 years of age: consult a doctor
OTHER SAFETY INFORMATION
Store at Room Temperature
INACTIVE INGREDIENT SECTION
Water, Propylene Glycol, Edetate Disodium
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 82199-610-26 7.7ml in 1 Vial
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82199-610-26 | 2023-01-30 | C162847 | 48780-1 | f386c649-c071-0266-e053-dadaa90a7c1a | d11f5df7-b239-a407-e053-2995a90a728b |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82199-610-26 | First Aid Antiseptic Pain Relieving | 7.7 mL in 1 VIAL | SPRAY | 7.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82199-610 | FIRST AID ANTISEPTIC PAIN RELIEVING (BENZALKONIUM CHLORIDE,PRAMOXINE HYDROCHLORIDE) SPRAY [SHANDONG RUIAN PHARMACEUTICAL CO.,LTD.] | 1 | Legacy NDC, 1 package rows | 20211121_d11f5df7-b239-a407-e053-2995a90a728b.zip |
Products#
Every source-derived product name is available through these pages.
- First Aid Antiseptic Pain Relieving
- BENZALKONIUM CHLORIDE,PRAMOXINE HYDROCHLORIDE
- WATER
- EDETATE DISODIUM
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- PROPYLENE GLYCOL
- PRAMOXINE HYDROCHLORIDE
- PRAMOXINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82199-610 | 82199-610-26 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| d11f5df7-b23a-a407-e053-2995a90a728b | d11f5df7-b239-a407-e053-2995a90a728b | 2021-11-19 | Warnings | d11f5df7-b23a-a407-e053-2995a90a728b d11f5df7-b239-a407-e053-2995a90a728b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.