Label: STRESSA BACK AND NECK PAIN RELIEVING- menthol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53882-001-01, 53882-001-02, 53882-001-03, 53882-001-04 - Packager: Stressa Incorporated
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 5, 2012
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
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Inactive Ingredients
arabica coffee oil, basil oil, cananga oil, carbomer homopolymer type C (allyl pentaerythritol crosslinked), cetostearyl alcohol, coconut oil, dimethicone, galbanum oil, glycerin, glyceryl monostearate, hyssop oil, lemon oil, methyl salicylate, nutmeg oil, palm oil, peppermint oil, phenoxyethanol, picea mariana leaf oil, pine needle oil (pinus sylvestris) polyoxyl 20 cetostearyl ether, rosemary oil, sage oil, shea butter, sodium citrate, sunflower seed oil, tocopherol, water, white wax
- PRINCIPAL DISPLAY PANEL - 43g Jar Carton
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INGREDIENTS AND APPEARANCE
STRESSA BACK AND NECK PAIN RELIEVING
menthol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53882-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 1.25 g in 100 g Inactive Ingredients Ingredient Name Strength white wax (UNII: 7G1J5DA97F) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) coconut oil (UNII: Q9L0O73W7L) dimethicone (UNII: 92RU3N3Y1O) lemon oil (UNII: I9GRO824LL) Nutmeg oil (UNII: Z1CLM48948) Peppermint oil (UNII: AV092KU4JH) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) Rosemary oil (UNII: 8LGU7VM393) Sage oil (UNII: U27K0H1H2O) PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O) CANANGA OIL (UNII: 8YOY78GNNX) Basil oil (UNII: Z129UMU8LE) ARABICA COFFEE OIL (UNII: IK55HKE887) Galbanum oil (UNII: 211UF7M8N1) Hyssop oil (UNII: 173D71924B) METHYL SALICYLATE (UNII: LAV5U5022Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) glycerin (UNII: PDC6A3C0OX) glyceryl monostearate (UNII: 230OU9XXE4) palm oil (UNII: 5QUO05548Z) phenoxyethanol (UNII: HIE492ZZ3T) shea butter (UNII: K49155WL9Y) sunflower oil (UNII: 3W1JG795YI) sodium citrate (UNII: 1Q73Q2JULR) tocopherol (UNII: R0ZB2556P8) water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53882-001-02 1 in 1 BOX 1 NDC:53882-001-01 43 g in 1 JAR 2 NDC:53882-001-04 1 in 1 BOX 2 NDC:53882-001-03 85 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 12/03/2012 Labeler - Stressa Incorporated (031377428) Establishment Name Address ID/FEI Business Operations Stressa Incorporated 031377428 MANUFACTURE(53882-001)
