Storage and handling
Other information Store between 20 o C and 25 o C (68 o F and 77 o F) Lot No. and Exp. Date: see box or see crimp of tube
Other information Store between 20 o C and 25 o C (68 o F and 77 o F) Lot No. and Exp. Date: see box or see crimp of tube
Active ingredients (in each gram) Purpose
Neomycin 3.5mg .......................................................................................................First aid antibiotic
Polymyxin B sulfate 10,000 units ................................................................................First aid antibiotic
Pramoxine hydrochloride 10mg ...................................................................................Pain reliever
Uses
first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
Warnings
For external use only
Do not use
Ask a doctor before use if you have
Stop use and ask a doctor if
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions Adults and children 2 years and older:
Children under 2 years: ask a doctor
Other information
Inactive ingredients
cetanol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid
Distributed by:
Midwood Brands, LLC
10811 Monroe Rd.
Matthews, NC 28105
Made in Korea
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1359360 | neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream | PSN | 5 |
| 1359360 | neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream | SCD | 5 |
| 1359360 | neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream | SY | 5 |
| 1359360 | neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream | SY | 5 |
| 1359360 | neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream | SY | 5 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NEOMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55319-033-28 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-6a15-a426-e053-dadaa90af4c2 | Family Wellness Triple Antibiotic Pain Relief Cream 1 oz. 3326 (2018) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55319-033-28 | FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF | 28 g in 1 TUBE | CREAM | 28 | 5 | |
| 55319-033-28 | FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF | 1 in 1 CARTON | CREAM | 1 | 5 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55319-033 | FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HCI) CREAM [FAMILY DOLLAR] | 5 | Legacy NDC, 2 package rows | 20190201_9f0313a2-3e80-4b93-8362-3e5ea55b29e7.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NEOMYCIN | ACTIVE INGREDIENT | I16QD7X297 | 2 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | 2 | |
| PRAMOXINE HYDROCHLORIDE | ACTIVE INGREDIENT | 88AYB867L5 | 2 | |
| NEOMYCIN | ACTIVE MOIETY | I16QD7X297 | 2 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | 2 | |
| PRAMOXINE | ACTIVE MOIETY | 068X84E056 | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 2 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55319-033 | 55319-033-28 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| WATER | 059QF0KO0R | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| CETYL ALCOHOL | 936JST6JCN | IACT |
| PARAFFIN | I9O0E3H2ZE | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| NEOMYCIN SULFATE | 057Y626693 | ACTIM |
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
| PRAMOXINE HYDROCHLORIDE | 88AYB867L5 | ACTIB |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | OINTMENT / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | AEROSOL, FOAM / TOPICAL | 7.9 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET / ORAL | 113.75 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / VAGINAL | 22 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / VAGINAL | 200 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | POWDER, FOR SUSPENSION / ORAL | 1203 mg/5ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / SUBLINGUAL | 36 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOLUTION / TOPICAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / SUBCUTANEOUS | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | PASTE, DENTIFRICE / DENTAL | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / ORAL | 62.5 mg/5ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / NASAL | 14 mg |
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 |
|---|---|---|---|---|---|---|
| 80c68765-ae5a-d554-e053-2a91aa0a966f | 9f0313a2-3e80-4b93-8362-3e5ea55b29e7 | 2019-01-31 | Warnings | 80c68765-ae5a-d554-e053-2a91aa0a966f 9f0313a2-3e80-4b93-8362-3e5ea55b29e7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.