Indications and uses
temporarily relieves minor pain
Thera Plus Max Strength Lidocaine Pain Relief Liquid
- Manufacturer
- Fourstar Group USA, Inc.
- Effective date
- 2023-11-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:08:06
Label at a glance#
ProductThera Plus Max Strength Lidocaine Pain Relief Liquid
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections
Dosage and administration
adults and children over 12 years: • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. • children 12 years or younger. ask a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
Lidocaine HCI 4%
Purpose
Topical analgesic
Uses
temporarily relieves minor pain
Warnings
For external use only.
Flammable •keep away from fire or flame
Do not use
• on large areas of the body or on cut, irritated or swollen skin • on puncture wounds • for more than one week without consulting a doctor
When using this product
• use only as directed. Read and follow all directions and warnings in this carton. • do not allow contact with the eyes and mucous membranes • do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use • do not use at the same time as other topical analgesics
Stop use and ask a doctor if
• condition worsens • redness is present • irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children over 12 years: • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. • children 12 years or younger. ask a doctor
Other information
- store at 20° - 25°C (68° - 77°F)
- store in a cool dry place away from direct sunlight
Inactive ingredients
acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, cetearyl alcohol, ceteth-10 phosphate, cyclopentasiloxane, dicetyl phosphate, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, sd alcohol, steareth-21, water
Questions or comments?
1-800-639-3803 Weekdays 9 AM to 4 PM EST
Package Labeling:
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80684-098-00 | Thera Plus Max Strength Lidocaine Pain Relief Liquid | 74 mL in 1 BOTTLE | LIQUID | 74 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Thera Plus Max Strength Lidocaine Pain Relief Liquid
- LIDOCAINE HYDROCHLORIDE
- ALOE VERA LEAF
- AMINOMETHYLPROPANOL
- CETOSTEARYL ALCOHOL
- CETETH-10 PHOSPHATE
- CYCLOMETHICONE 5
- DIHEXADECYL PHOSPHATE
- DIMETHICONE
- EDETATE DISODIUM ANHYDROUS
- ETHYLHEXYLGLYCERIN
- GLYCERYL MONOSTEARATE
- ISOHEXADECANE
- PHENOXYETHANOL
- STEARETH-21
- WATER
- LIDOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 80684-098 | 80684-098-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| Thera Plus Max Strength Lidocaine Pain Relief Liquid | LIDOCAINE HYDROCHLORIDE | Fourstar Group USA, Inc. | 0a228b06-0e1c-6c75-e063-6294a90a9a0e | 2023-11-30 | Warnings | 80684-098-00 80684-098 80684009800 0b61e01d-3530-d2a1-e063-6294a90a513c 0a228b06-0e1c-6c75-e063-6294a90a9a0e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.