Label: NEURITERX- capsaicin 0.05% cream
- NDC Code(s): 57483-221-01
- Packager: Innovus Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 8, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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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
- Keep out of reach of children
- Directions
- Other Information
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
NEURITERX
capsaicin 0.05% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57483-221 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN .05 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:57483-221-01 1 in 1 CARTON 02/02/2021 1 56.7 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M 02/02/2021 Labeler - Innovus Pharmaceuticals, Inc. (962507187) Registrant - Innovus Pharmaceuticals, Inc. (962507187) Establishment Name Address ID/FEI Business Operations Topical Pharmaceuticals Inc. 831530683 manufacture(57483-221)