Search by Drug Name or NDC

NDC 70859-0028-04 NuDroxicin pain relief Roll-On .25; 60; 250 mg/mL; mg/mL; mg/mL Details

NuDroxicin pain relief Roll-On .25; 60; 250 mg/mL; mg/mL; mg/mL

NuDroxicin pain relief Roll-On is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by NuCare Pharmaceuticals Inc. The primary component is CAPSAICIN; MENTHOL; METHYL SALICYLATE.

Product Information

NDC	70859-0028
Product ID	70859-028_6492c511-c484-c337-e053-2a91aa0a3916
Associated GPIs	90809903300930
GCN Sequence Number	078606
GCN Sequence Number Description	capsaicin/me-salicylate/menth LIQUID 0.025%-25% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	44964
HICL Sequence Number	002572
HICL Sequence Number Description	CAPSAICIN/METHYL SALICYLATE/MENTHOL
Brand/Generic	Brand
Proprietary Name	NuDroxicin pain relief Roll-On
Proprietary Name Suffix	n/a
Non-Proprietary Name	METHYL SALICYLATE, MENTHOL, CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	.25; 60; 250
Active Ingredient Units	mg/mL; mg/mL; mg/mL
Substance Name	CAPSAICIN; MENTHOL; METHYL SALICYLATE
Labeler Name	NuCare Pharmaceuticals 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 70859-0028-04 (70859002804)

Pricing Information	N/A
NDC Package Code	70859-028-04
Billing NDC	70859002804
Package	1 CONTAINER in 1 CARTON (70859-028-04) / 90 mL in 1 CONTAINER
Marketing Start Date	2017-11-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6492c511-c483-c337-e053-2a91aa0a3916 Details

DRUG FACTS:

ACTIVE INGREDIENTS:

Methyl Salicylate 25.00%

Menthol 6.00%

Capsaicin 0.025%

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 of 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 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 Labeling:

INGREDIENTS AND APPEARANCE

NUDROXICIN PAIN RELIEF ROLL-ON

methyl salicylate, menthol, capsaicin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70859-028
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	250 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	60 mg in 1 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
YELLOW WAX (UNII: 2ZA36H0S2V)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN OLIVATE (UNII: MDL271E3GR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70859-028-03	1 in 1 CARTON	02/06/2018
1		90 mL in 1 CONTAINER; 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	11/18/2017

Labeler - NuCare Pharmaceuticals Inc (010632300)

Revised: 2/2018

Document Id: 6492c511-c484-c337-e053-2a91aa0a3916

Set id: 6492c511-c483-c337-e053-2a91aa0a3916

Version: 2

Effective Time: 20180206