FDA.reportPublic FDA data

RX300 Topical Pain Cream

Manufacturer
BENERX LLC | Dhaliwal Pharmaceuticals Laboratories LLC
Effective date
2022-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:42:13

Label at a glance#

ProductRX300 Topical Pain Cream Pain Cream
Active ingredientLIDOCAINE, MENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC Active

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Menthol 4%Topical Analgesic
Lidocaine 4%Topical Anesthetic

OTC - DO NOT USE SECTION

Do Not Use

  • On wounds or damaged skin
  • With a heating pad
  • On children under 12 year of age
  • If pregnant or breast feeding

OTC - PURPOSE SECTION

Topical Pain Cream

WARNINGS AND PRECAUTIONS SECTION

Warnings:

For external use only

  • Avoid contact with eyes and mucous memberanes
  • Do not bandage tightly

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and ask a doctor if

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Excessive skin irritation occurs

OTC - STOP USE SECTION

Stop use and ask a doctor if:

  • Condition worsens or symptoms persists for more than 7 days
  • Excessive skin irritation occurs
  • Symptoms clear up and occur again within a few days

DOSAGE & ADMINISTRATION SECTION

Directions

  • Use as directed
  • Adults and children 12 years of age and older, rub a thin layer to affected area 3-4 times daily
  • Children under 12 years of age consult a physician
  • wash hands after applying

INACTIVE INGREDIENT SECTION

Water (Aqua, Eau)

cetearyl alcohol

polysorbate 60

Caprylic/ Capric Triglyceride

Glycerin

Glyceryl Stearate

Peg 100 Stearate

Aloe Barbadensis (Aloe) Leaf Juice

Phenoxyethanol

Triethanolamine

Carbomer

Panthenol

Methylsulfonyl Methane

Argania Spinosa Kernel Oil

Lavandula Angustifolia (Lavender) Oil

Glucosamine hydrocholride

Cannabis Sativa Hemp Oil

Boswellia Serrate Extract

Ethylhexylglycerin

Mentha Anensis (Peppermint) Leaf Oil

Rosmarinus Officinalis (Rosemary) Leaf Oil

Magnesium Sulfate

Choline Chloride

Camphor

Eucalyptus Globulous Leaf Oil

Curcuma Longa (Turmeric) Root Extract

WARNINGS SECTION

Warnings:

  • For external use only
  • Avoid contact with eyes and mucous memberanes
  • Do not bandage tightly

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CBD BoxCBD BoxTubeTube

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79884-00179884-001-01, 79884-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
TURMERIC856YO1Z64FIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CHOLINEN91BDP6H0XIACT
POLYSORBATE 60CAL22UVI4MIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
EUCALYPTUS OIL2R04ONI662IACT
PEPPERMINT OILAV092KU4JHIACT
LAVENDER OILZBP1YXW0H8IACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
ARGAN OIL4V59G5UW9XIACT
TROLAMINE9O3K93S3TKIACT
ROSEMARY OIL8LGU7VM393IACT
MENTHOLL7T10EIP3AACTIB
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER 9404Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT

Source Document#

Source XML

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
f117d2cd-ada3-c746-e053-2995a90a0ebbac796dea-b9e4-4110-e053-2995a90a30db2022-12-30WarningsExact identifier
spl id: f117d2cd-ada3-c746-e053-2995a90a0ebb
spl set id: ac796dea-b9e4-4110-e053-2995a90a30db

Reported adverse events (FAERS/openFDA)#

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