INSTASOOTHE PAIN RELIEF- menthol, capsaicin cream 
Eco Health, Inc.

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InstaSoothe Pain Relief Cream

DRUG FACTS:

Active Ingredient:

Menthol 2.00%

Capsaicin 0.025%

Topical Analgesic

INDICATIONS:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains bruises and strains.

WARNINGS:

  • For external use only
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

Do not apply

  • to open wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

  • contact physician prior to use.

DIRECTIONS:

  • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
  • Children under two-years of age: consult a physician.

ADDITIONAL INFORMATION:

Store at room temperature.

OTHER INGREDIENTS:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arcticum Lappa (Burdock) Root Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, PEG-8, Phenoxyethanol, Salix Alba (Willow) Bark Extract, Sodium Lauryl Sulfate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

Label

INSTASOOTHE PAIN RELIEF 
menthol, capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72514-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL20 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72514-353-00100 mL in 1 TUBE; Type 0: Not a Combination Product08/20/201801/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/20/201801/30/2021
Labeler - Eco Health, Inc. (052405711)

Revised: 10/2023
Document Id: 07243c32-7e99-ef27-e063-6394a90a3886
Set id: 271a179a-dc9b-4652-8b10-2ab109381793
Version: 2
Effective Time: 20231007
 
Eco Health, Inc.