Indications and uses
For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should only be under the advice and supervision of a doctor.
Welly First Aid Kit Refill
- Manufacturer
- Dongguan Shenglian Tins Products Co., Ltd.
- Effective date
- 2025-12-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:31:17
Label at a glance#
ProductWelly First Aid Kit Refill
Active ingredientHYDROCORTISONE, LIDOCAINE HYDROCHLORIDE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
Label structure25 sections
Dosage and administration
● Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. ● Children under 2 years of age: Do not use and ask a doctor.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Hydrocortisone 1%
Purpose
Anti-itch
Uses
For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Other uses of product should only be under the advice and supervision of a doctor.
Warnings
For external use only.
Do not use
● in the eyes ● for treatment of diaper rash, consult a doctor.
Stop use, ask a doctor
● if condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days ● with use of any other hydrocortisone product
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
● Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. ● Children under 2 years of age: Do not use and ask a doctor.
Other Information
● Store at 20° to 25°C (68° to 77°F).
● Do not use open or torn packets.
Inactive Ingredients
Ceteareth-20, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Petrolatum, Phenoxyethanol, Water
Questions or comments?
Call 1-833-BE-WELLY (1-833-239-3559)
Active Ingredient
Lidocaine HCl 2.0%
Purpose
TopicaI Pain Relief
Uses
For temporary pain relief associated with minor burns
Warnings
For external use only.
Do not use
- in large quantities particularly, over raw or blistered areas
- in the eyes. If this happens flush thoroughly with water
Stop use, ask a doctor if
- condition worsens, or if symptoms persist for more than 7 days or clears up and occurs again within a few days
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
- Adults and children 2 years of age and older:Apply to affected area not more than 3 to 4 times daily.
- Children under 2 years of age:Do not use, consult a doctor.
Other Information
- Store at 20° to 25°C to (68° to 77°F).
- Do not use open or torn packets.
Inactive Ingredients
Aloe Barbadensis leaf Juice , Aminomethyl Propanol, Carbomer, EthylhexyIglycerin, Maltodextrin, Menthol, Phenoxyethanol,Polyethylene Glycol, Purified Water, Tocopheryl Acetate.
Questions or comments?
call 1-833-BE-WELLY (1-833-239-3559)
Active Ingredients (each gram contains)
Bacitracin Zinc 400 units
Neomycin Sulfate 3.5 mg
Polymyxin B Sulfate 5,000 units
Purposes
First aid antibiotic
Uses
First aid to help prevent infection in minor: ● Cuts ● Scrapes ● 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 ingredients
Ask a doctor before use if you have
deep or puncture wounds, animal bites or serious burns.
Stop use and ask a doctor if
● Condition persists or gets worse. ● You need to use longer than 1 week. ● A rash or other allergic reaction develops.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
● Clean affected area and dry thoroughly. ● Apply small amount of product (amount equal to the surface area of the tip of a finger) on the area not more than 1-3 times daily ● May be covered by sterile bandage. ● Children under 2 years of age: Do not use, consult a doctor.
Other information
● Store at 20° to 25°C (68° to 77°F).
● Do not use open or torn packets.
Inactive ingredients
Mineral Oil, White Petrolatum
Questions or comments?
Call 1-833-BE-WELLY (1-833-239-3559)
Package Labeling:
Package Labeling:84956-011-01
Package Labeling:84956-017-01
Package Labeling:84956-007-01
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | PSN | 1 |
| 1011852 | lidocaine HCl 2 % Topical Gel | PSN | 1 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 1 |
| 106258 | hydrocortisone 10 MG/ML Topical Cream | SCD | 1 |
| 1011852 | lidocaine hydrochloride 0.02 MG/MG Topical Gel | SCD | 1 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 1 |
| 106258 | hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 % Topical Cream | SY | 1 |
| 106258 | hydrocortisone 1 GM per 100 GM Topical Cream | SY | 1 |
| 1011852 | lidocaine hydrochloride 2 % Topical Jelly | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BACITRACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NEOMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84956-011-01 | Welly First Aid Kit Refill | 0.9 g in 1 PACKET | CREAM | 0.9 g | 10 mg in 1g | 1 |
| 84956-016-01 | Welly First Aid Kit Refill | 1 in 1 KIT | KIT | 1 | 1 |
Products#
Every source-derived product name is available through these pages.
- Welly First Aid Kit Refill
- HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE
- Hydrocortisone
- CETEARETH-20
- CETOSTEARYL ALCOHOL
- ETHYLHEXYLGLYCERIN
- GLYCERIN
- GLYCERYL MONOSTEARATE
- MINERAL OIL
- PETROLATUM
- PHENOXYETHANOL
- WATER
- Welly Burn
- LIDOCAINE HYDROCHLORIDE
- ALOE BARBADENSIS LEAF JUICE
- AMINOMETHYL PROPANOL
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- MALTODEXTRIN
- MENTHOL
- POLYETHYLENE GLYCOL, UNSPECIFIED
- .ALPHA.-TOCOPHEROL ACETATE
- LIDOCAINE
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- Welly Triple Antibiotic First Aid
- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
- WHITE PETROLATUM
- BACITRACIN ZINC
- BACITRACIN
- NEOMYCIN SULFATE
- NEOMYCIN
- POLYMYXIN B SULFATE
- POLYMYXIN B
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84956-016 | 84956-016-01 |
| 84956-011 | 84956-011-01 |
| 43473-049 | |
| 84956-017 | 84956-017-01 |
| 43473-062 | |
| 84956-007 | 84956-007-01 |
| 69571-888 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N000004-004 | PAREDRINE | HYDROXYAMPHETAMINE HYDROBROMIDE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N000004-004 | PAREDRINE | 1% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Welly Polka First Aid Kit | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Dongguan Shenglian Tins Products Co., Ltd. | d7c4314c-c4c6-4adf-b384-3ac7a7108319 | 2025-12-17 | Warnings | 84956-007-01 84956-011-01 84956001101 84956000701 |
| Welly First Aid Kit Refill | HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE | Dongguan Shenglian Tins Products Co., Ltd. | 4bc93855-4009-4b49-9fb4-e5864054153d | 2025-12-16 | Warnings | 84956-017-01 84956-007-01 84956-011-01 84956-016-01 84956-016 84956001101 84956001601 84956001701 84956000701 46191bd3-6f9b-f3f0-e063-6294a90a718a 4bc93855-4009-4b49-9fb4-e5864054153d |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | Front Pharmaceutical PLC | 3244d91e-6c6b-a351-e063-6294a90aa02d | 2025-04-08 | Warnings | 69571-888 |
| PO First Aid Series BURN | LIDOCAINE HYDROCHLORIDE | Nantong Health & Beyond Hygienic Products Inc. | f1c349a8-216d-4233-922e-c95329a33d1e | 2024-12-05 | Warnings | 43473-062 |
| Hydrocortisone | HYDROCORTISONE | Nantong Health & Beyond Hygienic Products Inc. | fbbbcc67-b46d-d41a-e053-6294a90aa55d | 2024-08-08 | Warnings | 43473-049 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.