Painsil Pain Relief Roll-on Liquid
FDA Label NDC 87848-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Painsil Llc for the product Painsil Pain Relief Roll-on (NDC 87848-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Lidocaine hydrochloride 4.00%

Purpose

Topical Analgesic

Uses:

  • For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, or poison sumac.

Warnings:

For external use only

Do Not Use

  • In large quantities, particularly over raw surfaces or blistered areas.

When Using This Product

  • Avoid contact with the eyes

Stop Use And Ask A Doctor If

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Other Information

  • Store at 20–25°C (68–77°F) and protect from moisture.

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Menthol, Polysorbate 60, Sorbitan Isostearate, Steareth-2, Steareth-21, Water (Aqua)

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