Sano Ti Amo Relief And Repair Pain Relief Cream
FDA Label NDC 80216-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sano Ti Amo, Llc for the product Sano Ti Amo Relief And Repair Pain Relief (NDC 80216-111). 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 other, active ingredients, purpose, indications & usage, warnings:, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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NDC# 80216-111-02

Active Ingredients

Camphor .3 %

Menthol 1.25%

Purpose

Topical Analgesic

Topical Analgesic

Indications & Usage

USE for the temporary relief of aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings:

  • External Use Only
  • Avoid contact with eyes, open cuts, damaged or irritated skin or sensitive areas.
  • Do not use if allergic to any of the ingredients.

    • Those taking Coumadin (blood thinner or warfarin type medications) or have kidney issues/failure should consult their physician before using.

    • Do not use with other topical products.
    • Do not use if pregnant or nursing.
    • Do not bandage.
    • Do not apply heat.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center immediately.

Directions

  • Adults – 18 and over
  • Apply and gently massage into painful joints and or muscles.
  • Repeat as needed, no more than 4 times per day. Wash hands after each use.

Other Information

* Store at room temperature, protect from excessive heat

Inactive Ingredients

Water, Isopropyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Stearyl Alcohol, Glycerine, Hetoxol C, Cetyl Alcohol, Gamma-aminobutyric Acid, Dimethyl Sulfone (MSM), Calendula Officinalis Flower Extract, Arnica Montana Flower Extract, Echinacea, Astragalus Propinquus Root, Phenoxyethanol, Ethylhexylglycerin, Mentha Piperita (Peppermint) Oil, Bacopa Monnieri Extract, Baptisia Tinctoria, Butyrospermum Parkii (Shea Butter), Hemp Seed Oil, Vitamin B6, Hemp Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil.

Questions & Comments:

330-940-2129
www.sanotiamo.com
Deerfield, Ohio 44411

Principal Display Panel – 2 Oz Container Label

SANO TI AMO LLC

Relief & Repair™

Pain Relief Cream

  • Extra Strength
  • Penetrates Quickly
  • Fast & Long Lasting Relief
  • 12 Restorative Botanicals
  • Doctor Recommended

    • RELIEF FROM
    THE INSIDE OUT

    Net Wt. 2 oz. (60 ml)

* Please review the disclaimer below.