DFS 75mg DR/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 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 Of Reach Of Children:

Consult Physician for children under 12.

Directions:

Other Ingredients:

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0228-2551-06

Diclofenac Sodium Delayed-Release Tablets, USP

75 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Actavis

60 Enteric-Coated Tablets

Rx Only

NDC 70859-028-03 NuDroxicin Pain Relief Roll On

NDC 70859-046-01

DFS 75MG DR/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:70859-046

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70859-046-01 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 60 Part 2 1 CONTAINER 90 mL

Part 1 of 2 DICLOFENAC SODIUM diclofenac sodium tablet, delayed release

Product Information Item Code (Source) NDC:0228-2551 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 75 mg

Inactive Ingredients Ingredient Name Strength HYPROMELLOSES MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED SILICON DIOXIDE STEARIC ACID FERROSOFERRIC OXIDE POLYVINYL ACETATE PHTHALATE ALUMINUM HYDROXIDE LACTOSE MONOHYDRATE (ANHYDROUS LACTOSE) POLYSORBATE 80 PROPYLENE GLYCOL SODIUM ALGINATE SODIUM STARCH GLYCOLATE TYPE A POTATO TALC TITANIUM DIOXIDE

Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code R;551 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0228-2551-06 60 TABLET, DELAYED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074514 03/26/1996

Part 2 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 CARBOXYPOLYMETHYLENE PHENOXYETHANOL ILEX PARAGUARIENSIS LEAF POLYSORBATE 20 SORBITAN OLIVATE CETEARYL OLIVATE YELLOW WAX ARNICA MONTANA FLOWER MAGNESIUM SULFATE, UNSPECIFIED ETHYLHEXYLGLYCERIN INDIAN FRANKINCENSE GLYCERYL MONOSTEARATE WATER DIMETHYL SULFONE

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

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074514 03/26/1996

Labeler — NuCare Pharmaceuticals,Inc. (010632300)

Establishment
Name	Address	ID/FEI	Operations
NuCare Pharmaceuticals,Inc.		010632300	manufacture (70859-046)

Revised: 05/2021 NuCare Pharmaceuticals,Inc.