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

SANO TI AMO RELIEF AND REPAIR PAIN RELIEF by

Drug Labeling and Warnings

SANO TI AMO RELIEF AND REPAIR PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Sano Ti Amo, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

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)

INGREDIENTS AND APPEARANCE

SANO TI AMO RELIEF AND REPAIR PAIN RELIEF 
menthol, unspecified form, camphor (synthetic) cream

Product 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)