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

2
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NDC 70859-028-03 NuDroxicin Pain Relief Roll On

pdp
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NDC 70859-046-01

pdp
(click image for full-size original)

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.

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