DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK (Page 7 of 7)

NuDroxicin Pain Relief Roll-On

Active Ingredients:

Methyl Salicylate 25.00%

Menthol 6.00%

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings:

For external use only. Use Only as directed . Avoid contact with eyes and mucous membranes or genitals.

Do not cover or tightly bandage area.

On wounds or damaged skin.

Do not use with heating pad.

Do Not Use:

On cuts or infected skin, on children less than 12 years old in large amount.

Stop Use And Ask A Physician:

For severe undiagnosed pain. If pain worsens or persist for more than 7 days . If itching or rash occurs

Keep Out if reach of Children

Consult Physician for children under 12.

Directions:

Shake before each use. Prior to first use rub small amount to check for sensitivity. Apply product directly to affected area. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Product may be used as necessary, but should not be used more than four times per day.

STORE BELOW (90°F/32°C)

Other Ingredits:

Aqua (Deionized Water), Arnica Montana Flower Extract, Beeswax, Boswellia Serrata Extract, Carbomer, Cetearyl Olivate, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Magnesium Sulfate, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Sorbitan Olivate, Triethanolamine

Principal Display Panel

PDP
(click image for full-size original)

NDC 70859-028-03 NuDroxicin Pain Relief Roll -On

pdp
(click image for full-size original)

NDC 70859-045-01

PDP
(click image for full-size original)

DFS 1.5%/MS 25%/MENTH 6%/CAP 0.025% PAK diclofenac sodium, methyl salicylate/menthol/capsaicin kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70859-045
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-045-01 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 CONTAINER 90 mL
Part 2 0 BOTTLE 1 mL
Part 1 of 2
NUDROXICIN PAIN RELIEF ROLL-ON methyl salicylate, menthol, capsaicin liquid
Product Information
Item Code (Source) NDC:70859-028
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 60 mg in 1 mL
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.25 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 250 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 20
SORBITAN OLIVATE
CETEARYL OLIVATE
YELLOW WAX
ARNICA MONTANA FLOWER
MAGNESIUM SULFATE, UNSPECIFIED
ETHYLHEXYLGLYCERIN
GLYCERYL MONOSTEARATE
CARBOXYPOLYMETHYLENE
INDIAN FRANKINCENSE
ILEX PARAGUARIENSIS LEAF
PHENOXYETHANOL
DIMETHYL SULFONE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70859-028-03 1 CONTAINER in 1 CARTON contains a CONTAINER
1 90 mL in 1 CONTAINER This package is contained within the CARTON (70859-028-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/07/2018
Part 2 of 2
DICLOFENAC SODIUM diclofenac sodium solution
Product Information
Item Code (Source) NDC:60505-0399
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
DIMETHYL SULFOXIDE
PROPYLENE GLYCOL
ALCOHOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60505-0399-5 1 BOTTLE in 1 CARTON contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the CARTON (60505-0399-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202027 05/28/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202769 07/29/2016
Labeler — Nucare Pharmaceuticals Inc (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals,Inc. 010632300 manufacture (70859-045)

Revised: 05/2021 Nucare Pharmaceuticals Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.