BeneRX MD RX300 Topical Pain Cream

RX300 Topical Pain Cream by

Drug Labeling and Warnings

RX300 Topical Pain Cream by is a Otc medication manufactured, distributed, or labeled by BENERX LLC, Dhaliwal Pharmaceuticals Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

RX300 TOPICAL PAIN CREAM PAIN CREAM- menthol, lidocaine cream 
BENERX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BeneRX MD RX300 Topical Pain Cream

OTC Active

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

Do Not Use

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

Topical Pain Cream

Warnings:

For external use only

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

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

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

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

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

Questions or Comments

www.benerxmd.com

Warnings:

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

CBD BoxTube

RX300 TOPICAL PAIN CREAM  PAIN CREAM
menthol, lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79884-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BOSWELLIA SERRATA WHOLE (UNII: X7B7P649WQ)  
TURMERIC (UNII: 856YO1Z64F)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
CHOLINE (UNII: N91BDP6H0X)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
ARGAN OIL (UNII: 4V59G5UW9X)  
TROLAMINE (UNII: 9O3K93S3TK)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79884-001-021 in 1 BOX08/01/2020
1NDC: 79884-001-0188 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2020
Labeler - BENERX LLC (113572537)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Pharmaceuticals Laboratories LLC116933772manufacture(79884-001)

Revised: 12/2022
Document Id: f117d2cd-ada3-c746-e053-2995a90a0ebb
Set id: ac796dea-b9e4-4110-e053-2995a90a30db
Version: 4
Effective Time: 20221230
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