DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Methyl Salicylate 30% Menthol 10% Capsaicin 0.025%
Available from:
Physicians Science & Nature Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic For temporary relief of mild pain due to muscular strain, arthritis, and simple back pain. Does not cure any disease. 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. 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.
Authorization status:
OTC monograph not final
Authorization number:
27495-014-02, 27495-014-04

DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion

Physicians Science & Nature Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dendracin Neurodendraxcin®, Topical Pain Relief Lotion

ACTIVE INGREDIENTS

Methyl Salicylate 30%

Menthol 10%

Capsaicin 0.025%

Purpos e

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 allow

treated skin to contact infants or pets. Do not tightly bandage. Do not use with heating pad. Do not use

with other topical pain products. May stain furniture.

Keep away from children and pets.

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.

Manufactured for Physician’s Science and Nature Inc.

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

Made in the USA

Patent Pending

Principal Display Panel

Physician's Science and Nature Inc.

DENDRACIN

Neurodendraxcin®

Professional Formula

Dermatologically Tested

Hypoallergenic

Topical Pain Relief Lotion

Deep Penetrating Action

60 ml (2 fl oz)

NDC 27495-014-02

2 oz Label

DENDRACIN NEURODENDRAXCIN

methyl salicylate, menthol and capsaicin lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:2749 5-0 14

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

18 g in 6 0 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

6 g in 6 0 mL

CAPSAICIN (UNII: S0 7O44R1ZM) (CAPSAICIN - UNII:S0 7O44R1ZM)

CAPSAICIN

0 .0 15 g in 6 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BENZO CAINE (UNII: U3RSY48 JW5)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIMETHYL SULFO XIDE (UNII: YOW8 V9 6 9 8 H)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

BO RAGE SEED O IL (UNII: F8 XAG1755S)

AMMO NIO METHACRYLATE CO PO LYMER TYPE A (UNII: 8 GQS4E6 6 YY)

GINGER (UNII: C5529 G5JPQ)

LECITHIN, SO YBEAN (UNII: 1DI56 QDM6 2)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

SO DIUM STEARO YL GLUTAMATE (UNII: 6 5A9 F4P0 24)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:2749 5-0 14-0 2

50 in 1 CARTON

0 7/22/20 11

1

6 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

2

NDC:2749 5-0 14-0 4

50 in 1 CARTON

0 7/22/20 11

2

120 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 7/22/20 11

Physicians Science & Nature Inc.

Labeler -

Physicians Science & Nature Inc. (012485755)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Westwo o d Labo rato ries Inc.

0 6 9 9 26 48 3

MANUFACTURE(2749 5-0 14)

Revised: 3/2019

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