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NDC 54102-0000-04 Q Health Pain Relief 80 mg/mL Details

Q Health Pain Relief 80 mg/mL

Q Health Pain Relief is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by QCAN International Inc.. The primary component is MENTHOL.

Product Information

NDC	54102-0000
Product ID	54102-000_968931a2-72b5-b12b-e053-2995a90a338e
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	Q Health Pain Relief
Proprietary Name Suffix	n/a
Non-Proprietary Name	MENTHOL
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mg/mL
Substance Name	MENTHOL
Labeler Name	QCAN International Inc.
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 54102-0000-04 (54102000004)

Pricing Information	N/A
NDC Package Code	54102-000-04
Billing NDC	54102000004
Package	1 BOTTLE in 1 CARTON (54102-000-04) / 120 mL in 1 BOTTLE
Marketing Start Date	2017-02-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL aa6d1beb-f462-4577-a57c-fb0ec12d4ce5 Details

Q Health Pain Relief Spray

Active Ingredient:

Menthol 8.00%

Purpose

External Analgesic

Directions:

Apply directly to affected area. Do not use more than four times per day.

Uses:

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

Warnings:

For external use only.
Avoid contact with eyes.
Do not bandage tightly.

Do not apply

on open wounds or damaged skin.

Discontinue use

If symptoms persist more than seven days, discontinue use and consult physician.

Keep out of reach of children.

If swallowed, consult physician.

If pregnant or breast feeding,

contact physician prior to use.

Other Ingredients:

Aqua (Deionized Water), Arnica Montana Extract, Boswella Serrata Extract, Bromelain, Chondroitin Sulfate, Citric Acid, Dimethyl Sulfone (MSM), Eucalyptus Globulus Oil, Glucosamine Sulfate, Glycrrhiza Glabra (Licorice) Extract, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Magnesium Sulfate, Mentha Piperita (Peppermint) Oil, Methylisothiazolinone, Polysorbate-20, Polysorbate-80, Propylene Glycol, SD-Alcohol 40B.

PRINCIPAL DISPLAY PANEL

Q Health PAIN Relief Spray Fast temporary relief of minor aches and pains associated with simple backache arthritis, strains, bruises, sprains Contains Magnesium and Glucosamine Chondroitin MSM www.qcan.ca 4 FL OZ (120ML) Manufactured for QCAN INTERNATIONAL 1581 Crimson Cres. Kingston ON, K7P 0J3 Canada.

Product Labels

INGREDIENTS AND APPEARANCE

Q HEALTH PAIN RELIEF

menthol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54102-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	80 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA (UNII: O80TY208ZW)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
BROMELAINS (UNII: U182GP2CF3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54102-000-04	1 in 1 CARTON	02/07/2017
1		120 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	09/13/2012

Labeler - QCAN International Inc. (246834035)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(54102-000)

Revised: 11/2019

Document Id: 968931a2-72b5-b12b-e053-2995a90a338e

Set id: aa6d1beb-f462-4577-a57c-fb0ec12d4ce5

Version: 4

Effective Time: 20191104