NEURODEXX- pain relief lotion 
Rely Wellness

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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Neurodexx™ Pain Relief

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.

Keep Out Of Reach Of Children And Pets:

If swallowed get medical help or contact a Poison Control Center right away.

Warnings:

For external use only. Do not use in eyes, mouth or 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, clothing or bedding.

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/VP Copolymer, Zingiber Officinale Root Extract, Methylparaben, Propylparaben, Soy Lecithin, DMDM Hydantoin, Sodium Stearoyl Glutamate

Manufactured for: Rely Wellness
5777 W. Century Blvd, #1100 Unit #371, Los Angeles, CA 90045

Neurodexx™ Pain Relief

Hot Deep

Penetrating MAXIMUM STRENGTH

Topical Pain Relief Lotion

Provides Fast Temporary Relief from:


Doctor Recommended

120 ml (4 fl oz)
NDC 81649-030-04

Bottle

0.25gm (0.25 ml)

NDC 81649-030-25

Sample

NEURODEXX 
pain relief lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81649-030
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 60 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.015 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81649-030-250.25 mL in 1 PACKET; Type 0: Not a Combination Product05/01/2021
2NDC:81649-030-04120 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2021
Labeler - Rely Wellness (117943776)
Establishment
NameAddressID/FEIBusiness Operations
Westwood Laboratories Inc.832280635manufacture(81649-030)

Revised: 5/2021
Document Id: c14e7782-e535-7652-e053-2a95a90a7bbf
Set id: c14e75d4-12ca-7527-e053-2995a90a0e16
Version: 1
Effective Time: 20210501
 
Rely Wellness