Indications and uses
For temporary relief of pain and itching due to minor skin irritation.
Pain Prescriptives 4
- Manufacturer
- Sambria Pharmaceuticals | A.I.G. Technologies, Inc. | JP Packaging LLC
- Effective date
- 2018-08-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:48:32
Label at a glance#
ProductPain Prescriptives 4
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections
Dosage and administration
For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 50 to 60 seconds.
Contacts and useful links#
Label contents#
Full prescribing information#
Active Ingredient
Lidocaine HCL 4.00% w/w
Purpose
External Analgesic
Uses
For temporary relief of pain and itching due to minor skin irritation.
Warnings
For external use only
Avoid contact with eyes
OTC - DO NOT USE SECTION
Do not use in large quantities, particularly over raw surfaces or blistered areas
OTC - STOP USE SECTION
Stop use and ask a doctor if
• Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
• If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
For adults and children two-years or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician. Apply in a circular motion for 50 to 60 seconds.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chrondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexyglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.
Other Information
Protect this product from excessive heat and direct sun.
Questions or Comments?
FDA Registered: NDC No. 54723-724-02
800-642-1096
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Products#
Every source-derived product name is available through these pages.
- Pain Prescriptives 4
- LIDOCAINE HYDROCHLORIDE
- LIDOCAINE
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
- WATER
- ARNICA MONTANA FLOWER
- C13-14 ISOPARAFFIN
- SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)
- EMU OIL
- DIETHYLENE GLYCOL MONOETHYL ETHER
- ETHYLHEXYLGLYCERIN
- GLUCOSAMINE SULFATE
- ISOPROPYL PALMITATE
- LAURETH-7
- MELALEUCA ALTERNIFOLIA LEAF
- DIMETHYL SULFONE
- PHENOXYETHANOL
- POLYACRYLAMIDE (10000 MW)
- PROPYLENE GLYCOL
- STEARIC ACID
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54723-724 | 54723-724-02 |
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 |
|---|---|---|---|---|---|---|
| c38b48f3-c3e9-4f0a-89c7-138dfa2f7352 | f3ea5664-2dee-4ade-8e35-1612ee1c21af | 2018-08-06 | Warnings | c38b48f3-c3e9-4f0a-89c7-138dfa2f7352 f3ea5664-2dee-4ade-8e35-1612ee1c21af |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.