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NDC 63187-0136-04 Dendracin Neurodendraxcin .015; 6; 18 g/60mL; g/60mL; g/60mL Details

Dendracin Neurodendraxcin .015; 6; 18 g/60mL; g/60mL; g/60mL

Dendracin Neurodendraxcin is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE.

Product Information

NDC	63187-0136
Product ID	63187-136_30e14e19-9ab2-44d6-8aa5-297aa3aecf1a
Associated GPIs	90809903304124
GCN Sequence Number	067619
GCN Sequence Number Description	capsaicin/me-salicylate/menth LOTION 0.025%-30% TOPICAL
HIC3	L6A
HIC3 Description	IRRITANTS/COUNTER-IRRITANTS
GCN	30211
HICL Sequence Number	002572
HICL Sequence Number Description	CAPSAICIN/METHYL SALICYLATE/MENTHOL
Brand/Generic	Generic
Proprietary Name	Dendracin Neurodendraxcin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Methyl Salicylate, Menthol and Capsaicin
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	.015; 6; 18
Active Ingredient Units	g/60mL; g/60mL; g/60mL
Substance Name	CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63187-0136-04 (63187013604)

Pricing Information	N/A
NDC Package Code	63187-136-04
Billing NDC	63187013604
Package	50 BOTTLE in 1 CARTON (63187-136-04) / 120 mL in 1 BOTTLE
Marketing Start Date	2014-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 7e765fc1-74c6-4af3-a9cf-05b57011d7d8 Details

Active ingredients

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Purpose

Topical Analgesic

Uses:

For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease.

Warnings:

For external use only. Do not use in eyes, mouth, on mucous membranes, or genitals. Do not tightly bandage. Do not use with heating pad. Do not use with other topical pain products.

Keep away from children.

Directions:

Use only as directed. Shake before each use. Prior to first use, rub small amount to check for sensitivity. Gently rub over painful areas. Dry before contact with clothes or bedding to avoid staining. Wash hands after use. Do not use more than 4 times daily or if pregnant or nursing. If swallowed, call poison control. If placed into eyes, rinse with cold water and call a doctor.

Do Not Use:

On cuts or infected skin, on children less than 12 years old, in large amounts, especially over raw or blistered skin, if allergic to any ingredients, PABA, aspirin products, or sulfa.

Store below 90°F/32°C.

Stop Use and Ask a Physician:

For severe undiagnosed pain. If pain worsens or persist for more than 7 days. If pain clears up and then recurs in a few days. If itching or rash occurs.

Inactive ingredients:

Water, benzocaine, glyceryl stearate, PEG 100 stearate, stearic acid, cetyl alcohol, propylene glycol, dimethyl sulfoxide, triethanolamine, poloxamer 407, aloe barbadensis gel, borage oil, ammonium acryloyldimethyltaurate, zingiber officinale root extract, methylparaben, propylparaben, soya lecithin, DMDM hydantoin, sodium stearoyl glutamate.

SPL UNCLASSIFIED SECTION

Manufactured for Physicians' Science and Nature, Inc.

220 Newport Center Drive 11-634, Newport Beach, CA 92660

Made in the USA

Patent Pending

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Principal Display Panel

INGREDIENTS AND APPEARANCE

DENDRACIN NEURODENDRAXCIN

methyl salicylate, menthol and capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63187-136(NDC:27495-014)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	18 g in 60 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	6 g in 60 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.015 g in 60 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BENZOCAINE (UNII: U3RSY48JW5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BORAGE SEED OIL (UNII: F8XAG1755S)
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)
GINGER (UNII: C5529G5JPQ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63187-136-02	50 in 1 CARTON	08/01/2014
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:63187-136-04	50 in 1 CARTON	08/01/2014
2		120 mL in 1 BOTTLE; 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	07/22/2011

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(63187-136) , REPACK(63187-136)

Revised: 12/2021

Document Id: 30e14e19-9ab2-44d6-8aa5-297aa3aecf1a

Set id: 7e765fc1-74c6-4af3-a9cf-05b57011d7d8

Version: 3

Effective Time: 20211201