DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion

Dendracin Neurodendraxcin by

Drug Labeling and Warnings

Dendracin Neurodendraxcin by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., Physicians Science & Nature Inc., Westwood Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Relabeled by:

H.J. Harkins Company, Inc.

Nipomo, CA 93444

Made in the USA

Patent Pending

Principal Display Panel

Physicians' Science and Nature Inc.

Dendracin

Neurodendraxcin®

New Formula

Professional Formula

Topical Pain Relief Lotion

Deep Penetrating Action

120 ml (4 fl oz)

NDC: 27495-014-04

4 oz Label

INGREDIENTS AND APPEARANCE

DENDRACIN NEURODENDRAXCIN 
methyl salicylate, menthol and capsaicin lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-930(NDC:27495-014)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-930-12	50 in 1 CARTON
1		60 mL in 1 BOTTLE
2	NDC: 52959-930-60	50 in 1 CARTON
2		120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/22/2011

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Physicians Science & Nature Inc. (012485755)

Establishment
Name	Address	ID/FEI	Business Operations
Westwood Laboratories		069926483	MANUFACTURE