Santo Remedio Alivio Pain Relieving Lavender Scent Cream
FDA Label NDC 81352-519

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Santo Remedio Llc for the product Santo Remedio Alivio Pain Relieving Lavender Scent (NDC 81352-519). 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 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 HCl 4.00%
Menthol 1.00%

Purpose

Topical Analgesic

Uses

  • For the temporary relief of pain

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 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

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Emu Oil, Ethylhexylglycerin, Glucosamine Sulfate, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, PEG-8, Polysorbtate-80, Triethanolamine.

Questions?

855.REMEDIO

Package Labeling:

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