Label: SANO TI AMO RELIEF AND REPAIR PAIN RELIEF (menthol, unspecified form, camphor- synthetic cream
- NDC Code(s): 80216-111-02
- Packager: Sano Ti Amo, LLC
- 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 25, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- PURPOSE
- INDICATIONS & USAGE
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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
- OTHER INFORMATION
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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:
- Principal Display Panel – 2 oz Container Label
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INGREDIENTS AND APPEARANCE
SANO TI AMO RELIEF AND REPAIR PAIN RELIEF
menthol, unspecified form, camphor (synthetic) creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80216-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 13.4 mg in 1 mL CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 3.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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) CANNABIS SATIVA WHOLE (UNII: B5ONF538PB) TEA TREE OIL (UNII: VIF565UC2G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80216-111-02 60 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/08/2019 Labeler - Sano Ti Amo, LLC (117472990)
