Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 205a89c4-2ae4-4072-af5c-a9ce6154a3f9
Route
TOPICAL
Published
Effective Date 2025-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (13.4 mg) Camphor (synthetic) (3.0 mg)
Inactive Ingredients
Water Isopropyl Palmitate Sunflower Oil Stearyl Alcohol Glycerin Ppg-30 Cetyl Ether Cetyl Alcohol .gamma.-aminobutyric Acid Dimethyl Sulfone Echinacea Purpurea Flowering Top Echinacea Purpurea Root Echinacea Angustifolia Root Astragalus Propinquus Root Baptisia Tinctoria Bacopa Monnieri Whole Calendula Officinalis Flower Arnica Montana Phenoxyethanol Ethylhexylglycerin Peppermint Oil Shea Butter Cannabis Sativa Seed Oil Pyridoxine Cannabis Sativa Whole Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-08
Description

NDC# 80216-111-02

Purpose

Topical Analgesic Topical Analgesic

Medication Information

Indications and Usage

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical Analgesic

Topical Analgesic

Description

NDC# 80216-111-02

Section 42229-5

NDC# 80216-111-02

Section 50565-1

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

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.
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

Active Ingredients

Camphor .3 %

Menthol 1.25%

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)

Structured Label Content

Indications and Usage (34067-9)

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

NDC# 80216-111-02

Section 50565-1 (50565-1)

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

Purpose (PURPOSE)

Topical Analgesic

Topical Analgesic

Warnings: (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.
Directions (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 (OTHER INFORMATION)

* Store at room temperature, protect from excessive heat

Active Ingredients

Camphor .3 %

Menthol 1.25%

Inactive Ingredients (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 (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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:45.987882 · Updated: 2026-03-14T23:08:02.764471