INSTASOOTHE PAIN RELIEF- menthol, capsaicin cream

InstaSoothe Pain Relief by

Drug Labeling and Warnings

InstaSoothe Pain Relief by is a Otc medication manufactured, distributed, or labeled by Eco Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

INSTASOOTHE PAIN RELIEF 
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72514-353
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	20 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72514-353-00	100 mL in 1 TUBE; Type 0: Not a Combination Product	08/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/20/2018

Labeler - Eco Health, Inc. (052405711)