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

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

NDC 70859-045-01

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