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Soothee Patch Package Insert

The prescribing information is written for health professionals. Plain-language information for patients can be found in the patient information: dosage.

Status:
Prescription (Rx) Facts
Strength:
0.5 mg/10 g, 5 mg/10 g, 0.0375 g/10 g, 2 g/10 g
Drug class:
Active ingredients:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Soothee Patch

ACTIVE INGREDIENTS:

Lidocaine 0.5% External Analgesic

Menthol 5% External Analgesic/Counterirritant

Capsaicin 0.0375% External Analgesic

Methyl Salicylate 2% External Analgesic

USES:

Use for temporary relief of minor aches and muscle pains associated with arthritis, simple

backache, strains, sprains, muscle soreness and stiffness

WARNINGS:

  • For external use only. Use only as directed. Avoid contact with eyes and mucus membranes
  • Do not use on wounds or damaged skin
  • Stop use and ask a doctor if symptoms persist for more than seven days or clear up and occur again within a few days, or rahs, itching or excessive skin irritation occurs
  • Do not cover with bandage
  • Do no use if you are allergic to Menthol or Capsaicin
  • Consult physician for children under 12

DIRECTIONS:

  • Adults and children 12 years and over apply to affected area; change patch 2 to 3 times daily
  • Children under 12 years, consult a physician before use
  • How to apply:
  • Clean and dry affected area
  • Cut open pouch and remove patch
  • If desired, cut patch to size
  • Remove protective film and apply directly to area of pain
  • Apply to affected area not more than 3 times daily
  • Wash hands with soap after applying patch
  • Reseal pouch containing unused patches

INACTIVE INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80, Aloe

Barbadensis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt,

Diazolidinyl Urea, Methylparaben, Iodopropynyl Butylcabamate,

Propylparaben

Store below 77F (25C)

Avoid direct sunlight

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Soothee Patch

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Amide Local Anesthetic, Antiarrhythmic
Active ingredients Lidocaine 0.5 mg/10 g, Menthol 5 mg/10 g, Capsaicin 0.0375 g/10 g, Methyl salicylate 2 g/10 g
Dosage form Patch
Route Topical
Marketing status not in the current FDA NDC Directory
Company (applicant) Better Pain Solutions, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.5 mg/10 g, 5 mg/10 g, 0.0375 g/10 g, 2 g/10 g – 10 g in 1 patch / 15 in 1 box NDC 69592-001-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.