Label: SANO TI AMO RELIEF AND REPAIR PAIN RELIEF (menthol, unspecified form, camphor- synthetic cream

  • NDC Code(s): 66902-111-02
  • Packager: NATURAL ESSENTIALS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 21, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS     NDC # 66902-111-02

  • Active Ingredients

    Camphor .3%

    Menthol 1.5%

  • PURPOSE

    Topical Analgesic

    Topical Analgesic

  • 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.

    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

  • Principal Display Panel - 2 oz Container Label

    SANO TIAMO 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)

    Principal Display Panel - 2 oz Container Label
  • INGREDIENTS AND APPEARANCE
    SANO TI AMO RELIEF AND REPAIR PAIN RELIEF 
    menthol, unspecified form, camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM13.4 mg  in 1 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PPG-30 CETYL ETHER (UNII: 00C2W8NVII)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    .GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ECHINACEA PURPUREA FLOWERING TOP (UNII: 2EMS3QFX65)  
    ECHINACEA PURPUREA ROOT (UNII: OS64WTR4KU)  
    ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)  
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)  
    BAPTISIA TINCTORIA (UNII: 5K1UO2888Y)  
    BACOPA MONNIERI WHOLE (UNII: DUB5K84ELI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PYRIDOXINE (UNII: KV2JZ1BI6Z)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-111-0260 mL in 1 CONTAINER; Type 0: Not a Combination Product10/08/201911/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/08/201911/27/2021
    Labeler - NATURAL ESSENTIALS, INC. (947484713)