OTC Medication Information: FourPainRX

FOURPAINRX- capsaicin, methyl salicylate, menthol and lidocaine hydrochloride ointment
Neptune Products 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.

Active Ingredients

Lidocaine HCL 4%

Methyl Salicylate 27.5%

Menthol 10%

Capsaicin 0.0325%

Active Ingredients
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Topical Anesthetic

Topical NSAID

Topical Analgesic

Counterirritant

PurposePurpose

Temporarily relieves minor aches and muscles pains associated with:

  • arthritis
  • simple back pain
  • strains
  • muscle soreness
Instructions for use
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For external use only

Warnings
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Do not use

  • on open wounds, cuts, damaged or infected skin
  • with bandage or a heating pad
  • if condition worsens or symptoms persists for more than 7 days
  • excessive skin irritation occurs

Do  not use
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Ask a doctor before use if

Ask Doctor before use it
  • avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

When using
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If pregnant or breast feeding

ask a healthcare professional before use.

Pregnancy
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If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

Keep outKeep out

Store at at 20ºC — 25ºC (68ºF — 77ºF)

Store
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Directions

Adults 18 years and children 12 years and older:

  • apply product directly to affected area
  • product may be used as necessary, but should not be used more than four times per day.
  • wash hands immediately afterwards

Children 12 years or younger: ask a doctor

directions
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Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

Inact ingredients
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For Questions or Comments

Please Call 800-674-7939

Manufactured in the U.S.A. for:
Neptune Products LLC
Reno, NV 89501

questions
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NDC 72594-5000-1
FourPainRX™
Physician Formulated Ointment for Pain
Pain Relief Ointment
Lidocaine HCL
Methyl Salicylate
Menthol

Capsaicin
Net WT 4 oz. (121 g)

all
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FOURPAINRX
lidocaine hcl, methyl salicylate, menthol, capsaicin ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72594-5000
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.04 g in 121 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 33.28 g in 121 g
MENTHOL (MENTHOL) MENTHOL 12.1 g in 121 g
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 4.84 g in 121 g
Inactive Ingredients
Ingredient Name Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER
GLYCERYL STEARATE/PEG-100 STEARATE
PHENOXYETHANOL
STEARIC ACID
CETYL ALCOHOL
ALOE VERA LEAF
DIMETHICONE
GLYCERIN
CHAMOMILE
EDETATE DISODIUM
ALLANTOIN
GLYCERYL STEARATE SE
INULIN
ETHYLHEXYLGLYCERIN
WATER
TROLAMINE
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72594-5000-1 121 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 10/26/2020
Labeler — Neptune Products LLC (081502369)

Revised: 10/2021 Neptune Products LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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