DENDRACIN NEURODENDRAXCIN- methyl salicylate, menthol and capsaicin lotion lotion 
DirectRx

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

Methyl Salicylate 30%
Menthol 10%
Capsaicin 0.025%

Topical Analgesic

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.

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

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.

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.

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

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.

680

DENDRACIN NEURODENDRAXCIN 
methyl salicylate, menthol and capsaicin lotion lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-680(NDC:27495-014)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE18 g  in 60 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.015 g  in 60 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
AMMONIO METHACRYLATE COPOLYMER TYPE A (UNII: 8GQS4E66YY)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GINGER (UNII: C5529G5JPQ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
BORAGE SEED OIL (UNII: F8XAG1755S)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
BENZOCAINE (UNII: U3RSY48JW5)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61919-680-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2021
2NDC:61919-680-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/14/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/14/2021
Labeler - DirectRx (079254320)
Registrant - DirectRx (079254320)
Establishment
NameAddressID/FEIBusiness Operations
DirectRx079254320relabel(61919-680)

Revised: 3/2022
Document Id: db4b1818-f1e4-fca2-e053-2a95a90a3757
Set id: cbf560f0-3bc3-51df-e053-2a95a90ab298
Version: 3
Effective Time: 20220328
 
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