Simi-Tree Natural Pain Relief

Simi-Tree Natural Pain Relief by

Drug Labeling and Warnings

Simi-Tree Natural Pain Relief by is a Otc medication manufactured, distributed, or labeled by Higgins and Phillips Innovations Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SIMI-TREE NATURAL PAIN RELIEF- menthol cream 
Higgins and Phillips Innovations 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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Simi-Tree Natural Pain Relief

Active Ingredient(s)

Menthol 3% w/w. Purpose: Counter Irritant; Temporarily relieves aches and pains of muscles and joints associated with arthritis, backache, strains and sprains.

Purpose

Counter Irritant; Temporarily relieves aches and pains of muscles and joints associated with arthritis, backache, strains and sprains.

Direction For Use

DIRECTIONS FOR USE: Adults, adolescents, and children ≥ 2 years: Apply 1 to 4 pumps evenly to targeted area(s) up to 4 times per day; For children (2 - 12 years) applications should be supervised by an adult.

Warnings

For external use only; Avoid contact with eyes and mucous membranes;

DURATION OF USE: Consult a health care practitioner for use beyond 7 days. CAUTIONS AND WARNINGS: Call a Poison Control Center immediately if overdose or accidental ingestion occurs; Store in airtight, light-resistant container at room temperature; Stop use and consult a health care practitioner if symptoms worsen, re-occur within a few days; KNOWN ADVERSE REACTIONS: If you experience pain, swelling or blistering, stop use and get medical help right away; Stop use if hypersensitivity/allergy, rashes and/or burning discomfort occur.

Do not use

Do not apply to wounds or damaged skin; Do not tightly bandage; Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn. Safety sealed for your protection, do not use if seal is broken or missing

Known Adverse Reactions

KNOWN ADVERSE REACTIONS: If you experience pain, swelling or blistering, stop use and get medical help right away; Stop use if hypersensitivity/allergy, rashes and/or burning discomfort occur

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions For Use

DIRECTIONS FOR USE: Adults, adolescents, and children ≥ 2 years: Apply 1 to 4 pumps evenly to targeted area(s) up to 4 times per day

Other information

Store in airtight, light-resistant container at room temperature;

Inactive ingredients

Aloe Barbadensis Leaf Extract, Boswellia serrata (Frankincense) Essential Oil, Cetyl Alcohol, Cinnamomum zeylanicum (Ceylon Cinnamon) Bark Essential Oil, dl-Alpha-Tocopheryl Succinate, Ethylhexylglycerin, Eucalyptus polybractea (Eucalyptus) Essential Oil, Eugenia caryophyllus (Clove) Bud Essential Oil, Glycerin, Glyceryl Stearate, Grape Seed Oil, Hydroxylated Lecithin, Juniperus communis (Juniper) Fruit Essential Oil, Lavandula angustifolia (Lavender) Essential Oil, Magnesium Aluminum Silicate, Myristica fragrans (Nutmeg) Kernel Essential Oil, Oenothera biennis (Evening Primrose) Oil, Oleic Acid, Olive Oil, PEG-100 Stearate, Phenoxyethanol, Purified water, Rosmarinus officinalis (Rosemary) Leaf Essential Oil, Stearic Acid, Trolamine, Wheat Germ Oil, Xanthan Gum, Zingiber officinale (Ginger) Root Oil

Package Label - Principal Display Panel

Simi-Tree Natural Pain Relief Product LabelSimi-Tree Natural Pain Relief Product Label

Simi-Tree Natural Pain Relief Outter Box

Simi-Tree Natural Pain Relief BoxSimi-Tree Natural Pain Relief Box

SIMI-TREE NATURAL PAIN RELIEF 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 73807-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
GINGER OIL (UNII: SAS9Z1SVUK)  
JUNIPER BERRY OIL (UNII: SZH16H44UY)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
CINNAMON OIL (UNII: E5GY4I6YCZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
NUTMEG OIL (UNII: Z1CLM48948)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
.ALPHA.-TOCOPHEROL SUCCINATE, DL- (UNII: 7VJE08U49E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
WATER (UNII: 059QF0KO0R)  
WHEAT GERM OIL (UNII: 14C97E680P)  
CLOVE OIL (UNII: 578389D6D0)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
OLEIC ACID (UNII: 2UMI9U37CP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 73807-001-5050 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/15/202012/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34607/15/202012/31/2020
Labeler - Higgins and Phillips Innovations Inc. (204060180)
Registrant - Higgins and Phillips Innovations Inc. (204060180)
Establishment
NameAddressID/FEIBusiness Operations
Higgins and Phillips Innovations Inc.204060180manufacture(73807-001)

Revised: 4/2021