FDA.reportPublic FDA data

Dr.Johnes Lidocaine 4% Topical Analgesic Cream

Manufacturer
Dr.Johnes LLC
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:16

Label at a glance#

ProductDr.Johnes Lidocaine 4% Topical Analgesic Cream
Active ingredientLidocaine, MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient:

  1. Lidocaine HCl 4%
  2. Menthol 1%

OTC - PURPOSE SECTION

Purpose: Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: For temporary relief of minor aches and pains of muscles and joints associated with:

  1. Back pain
  2. Leg pain
  3. Hand and foot pain
  4. Minor nerve discomfort
  5. Muscle soreness

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use:

  • on open wounds or damaged skin.
  • in large quantities, especially over raw surfaces.
  • if allergic to lidocaine, menthol, or any ingredients in this product.

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes and mucous membranes.
  • Do not bandage tightly or use heating pad.
  • Discontinue use if excessive irritation occurs.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • condition worsens.
  • Symptoms persist for more than 7 days.
  • Severe burning, redness, or irritation develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding

Ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control immediately.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Apply a thin layer to affected area.
  • Use up to 3–4 times daily.
  • Rub gently until fully absorbed.
  • Wash hands after application unless treating hands.

INACTIVE INGREDIENT SECTION

Inactive ingredients:

The difference in ingredient naming between the SPL submission and the product packaging is due to differences in regulatory nomenclature and consumer-facing labeling conventions. The SPL uses standardized pharmaceutical ingredient names required for regulatory identification and electronic drug listing purposes, while the product packaging uses simplified or common names intended for consumer readability. Both representations refer to the same formulation and identical active and inactive ingredients, with no differences in strength, dosage form, or composition of the finished drug product. Any variation in terminology (e.g., INCI/common names vs. pharmacopoeial names) is solely for labeling clarity and does not reflect any difference in product identity or formulation. All naming differences are non-substantive and do not affect regulatory identity.

  • Purified Water (Water)
  • Propanediol
  • Butylene Glycol
  • MSM (Dimethyl Sulfone)
  • Magnesium Chloride
  • Aloe Vera Leaf Juice (Aloe Barbadensis Leaf Juice)
  • Caprylic/Capric Triglyceride (Medium Chain Triglycerides)
  • C12-15 Alkyl Benzoate (Alkyl Benzoate)
  • Dimethicone
  • Glyceryl Stearate (Glyceryl Monostearate)
  • PEG-100 Stearate (PEG-100 Monostearate)
  • Cetearyl Alcohol
  • Carbomer (Carbomer Homopolymer Type C)
  • Aminomethyl Propanol (Aminomethylpropanol)
  • Disodium EDTA (Edetate Disodium)
  • Phenoxyethanol
  • Ethylhexylglycerin
  • Dimethyl Isosorbide
  • Arnica Montana Flower Extract (Arnica Montana Flower)
  • Alpha Lipoic Acid
  • Tocopheryl Acetate (Vitamin E Acetate)
  • Pyridoxine Hydrochloride (Vitamin B6)

OTC - QUESTIONS SECTION

Questions or comments?

Contact us at support@drjohnes.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

neuropathy-Analgesicneuropathy-Analgesic

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85818-00785818-007-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPANEDIOL5965N8W85TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
EDETATE DISODIUM7FLD91C86KIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ALPHA LIPOIC ACID73Y7P0K73YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
Lidocaine98PI200987ACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-06-29weekly-update2026-07-17 21:42:13

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr.Johnes Lidocaine 4% Topical Analgesic CreamLIDOCAINE HCL,MENTHOLDr.Johnes LLC6144708d-4b0f-4f0d-88e3-6925ba2d004d2026-06-29WarningsExact identifier
ndc (package): 85818-007-01
ndc (product): 85818-007
ndc11 (package): 85818000701
spl id: 45f8588a-99a1-443e-b435-df1fef7f08a4
spl set id: 6144708d-4b0f-4f0d-88e3-6925ba2d004d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.