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NDC 70745-0749-01 Nopiate Topical Pain Relief .275; 50 mg/mL; mg/mL Details

Nopiate Topical Pain Relief .275; 50 mg/mL; mg/mL

Nopiate Topical Pain Relief is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Ezra Laboratories, Llc. The primary component is CAPSAICIN; MENTHOL.

Product Information

NDC	70745-0749
Product ID	70745-749_47f504d5-3eb8-5227-e054-00144ff88e88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Nopiate Topical Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	.275; 50
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAPSAICIN; MENTHOL
Labeler Name	Ezra Laboratories, Llc
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70745-0749-01 (70745074901)

Pricing Information	N/A
NDC Package Code	70745-749-01
Billing NDC	70745074901
Package	1 BOTTLE in 1 CARTON (70745-749-01) / 59 mL in 1 BOTTLE
Marketing Start Date	2016-05-28
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 613882a4-c078-4811-bd72-96c17a8d6a5c Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/28/2016

Labeler - Ezra Laboratories, Llc (080190761)

Revised: 2/2017

Document Id: 47f504d5-3eb8-5227-e054-00144ff88e88

Set id: 613882a4-c078-4811-bd72-96c17a8d6a5c

Version: 3

Effective Time: 20170207