SANO TI AMO RELIEF AND REPAIR PAIN RELIEF- menthol, unspecified form, camphor (synthetic) cream 
NATURAL ESSENTIALS, INC.

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.

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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
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)

Revised: 1/2021
Document Id: ff698feb-fe47-485a-bab8-bce7c2a9eb53
Set id: b6222294-657d-4257-b759-67f3f488e2d5
Version: 3
Effective Time: 20210121
 
NATURAL ESSENTIALS, INC.