NOPIATE TOPICAL PAIN RELIEF- menthol, capsaicin cream

Nopiate Topical Pain Relief by

Drug Labeling and Warnings

Nopiate Topical Pain Relief by is a Otc medication manufactured, distributed, or labeled by Ezra Laboratories, Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients:

Menthol 5.00%

Capsaicin 0.0275%

Purpose

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 wounds or damaged skin.

• Do not bandage tightly.

If pregnant or breast feeding,

contact physician prior to use.

Directions:

• Adults and children 2 years of age and older: Apply to the affected area no more than 3 to 4 times daily.
• Children under 2 years of age: Consult a physician.

Additional Information:

Store at room temperature.

Inactive ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Flower Extract, Boswellia Serrata, Emu oil, Ethylhexylglycerin, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Triethanolamine.

Package Labeling:

INGREDIENTS AND APPEARANCE

NOPIATE TOPICAL PAIN RELIEF 
menthol, capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70745-749
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg  in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.275 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70745-749-01	1 in 1 CARTON	05/28/2016
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/28/2016

Labeler - Ezra Laboratories, Llc (080190761)