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 Ingredients: Purpose
• 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

RX300 TOPICAL PAIN CREAM  PAIN CREAM
menthol, lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79884-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79884-001-02	1 in 1 BOX	08/01/2020
1	NDC: 79884-001-01	88 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/01/2020

Labeler - BENERX LLC (113572537)

Establishment
Name	Address	ID/FEI	Business Operations
Dhaliwal Pharmaceuticals Laboratories LLC		116933772	manufacture(79884-001)

Revised: 12/2022

Document Id: f117d2cd-ada3-c746-e053-2995a90a0ebb

34390-5

Set id: ac796dea-b9e4-4110-e053-2995a90a30db

Version: 4

Effective Time: 20221230

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