STRESSA BACK AND NECK PAIN RELIEVING- menthol oil 
Stressa Incorporated

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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Stressa Back & Neck Pain Relieving Oil

Drug Facts

Active ingredient

Menthol 1.25%

Purpose

topical analgesic

Uses

For the temporary relief of pain associated with

Warnings

For external use only.

When using this product

  • avoid contact with eyes
  • do not bandage tightly,

Stop use and ask a doctor if

  • conditions worsen or symptoms persist for more than 7 days
  • 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 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult a doctor.

Inactive ingredients

almond oil, alpha tocopherol (vitamin E), apricot kernel oil, arabica coffee oil, basil oil, cananga oil, european hazelnut oil, galbanum oil, hyssop oil, lemon juice, methyl salicylate, nutmeg oil, picea mariana leaf oil, pine needle oil (pinus sylvestris), rosemary oil, sage oil, wheat germ

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

Stressa

back & neck
pain relieving oil

all natural formula
for the soothing relief
of tense and sore
muscles

NET WT
8 fl oz (240 mL)

Principal Display Panel - 240 mL Bottle Label
STRESSA BACK AND NECK PAIN RELIEVING 
menthol oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53882-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1 g  in 93 mL
Inactive Ingredients
Ingredient NameStrength
ALMOND OIL (UNII: 66YXD4DKO9)  
APRICOT KERNEL OIL (UNII: 54JB35T06A)  
BASIL OIL (UNII: Z129UMU8LE)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
GALBANUM OIL (UNII: 211UF7M8N1)  
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
HYSSOP OIL (UNII: 173D71924B)  
LEMON OIL (UNII: I9GRO824LL)  
NUTMEG OIL (UNII: Z1CLM48948)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SAGE OIL (UNII: U27K0H1H2O)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
PICEA MARIANA LEAF OIL (UNII: Q1J49L1A5O)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WHEAT GERM (UNII: YR3G369F5A)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
CANANGA OIL (UNII: 8YOY78GNNX)  
Product Characteristics
ColorORANGE (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53882-002-0160 mL in 1 BOTTLE, PLASTIC
2NDC:53882-002-02118 mL in 1 BOTTLE, PLASTIC
3NDC:53882-002-03240 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/01/2014
Labeler - Stressa Incorporated (031377428)
Establishment
NameAddressID/FEIBusiness Operations
Stressa Incorporated031377428MANUFACTURE(53882-002)

Revised: 8/2014
Document Id: 11f9d65c-4717-4802-a8d9-921d4006c9ae
Set id: 8dc5dbff-a4d5-4b81-825b-25691cf9ac0f
Version: 1
Effective Time: 20140804
 
Stressa Incorporated