NEURITERX- capsaicin cream 
Semprae Laboratories 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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Capsaicin

Active Ingredient

Capsaicin 0.05% 

Purpose

Topical analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to

Warnings

For external use only

When using this product

• use only as directed
• do not bandage tightly
• do not use with heating pad
• avoid contact with eyes and mucous membranes
• do not apply to wounds, damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or symptoms clear up and occur again within a few days

Keep out of reach of children

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

Directions

Adults and children over 18 years:

Children 18 years or younger: ask a doctor

Other Information

Store at 20° - 25°C (68° - 77°F)
Do not use if inner container seal is damaged or missing.

Inactive Ingredients

Almond Oil, Benzyl Alcohol, Benzyl Benzoate, Butylated Hydroxytoluene, Carbomer Copolymer Type B, Cinnamon
Bark Oil, Coriander Oil, Edetate Disodium, Isopropyl Alcohol, L-Arginine HCl, L-Citrulline , Polyoxl 40 Hydrogenated Castor Oil,
Propylene Glycol, Sorbitol,Trolamine, Water

image description

NEURITERX 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72826-140
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZYL BENZOATE (UNII: N863NB338G)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
CORIANDER OIL (UNII: 7626GC95E5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
CITRULLINE (UNII: 29VT07BGDA)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72826-140-141 in 1 CARTON11/20/2020
156.7 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/20/2020
Labeler - Semprae Laboratories Inc (093739668)
Establishment
NameAddressID/FEIBusiness Operations
Topical Pharmaceuticals Inc.831530683manufacture(72826-140)

Revised: 11/2020
Document Id: bd04afdf-0c14-4d7e-b42a-45e935b07f73
Set id: 38130cd4-d589-4319-8a1a-b4a18dc72753
Version: 1
Effective Time: 20201120
 
Semprae Laboratories Inc