STRESSA BACK AND NECK PAIN RELIEVING- menthol cream 
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 Cream

Drug Facts

Active ingredient

Menthol 1.25%

Purpose

topical analgesic

Uses

For the temporary relief of minor aches & pains of muscles & joints associated with

Warnings

For external use only.

Do not apply to wounds or damaged skin

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

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

Stressa™

back & neck
pain relieving cream

for soothing relief
of tense and sore
muscles

net wt. 1.5oz (43g)

Principal Display Panel - 43g Jar Carton
STRESSA BACK AND NECK PAIN RELIEVING 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53882-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53882-001-021 in 1 BOX
1NDC:53882-001-0143 g in 1 JAR
2NDC:53882-001-041 in 1 BOX
2NDC:53882-001-0385 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/03/2012
Labeler - Stressa Incorporated (031377428)
Establishment
NameAddressID/FEIBusiness Operations
Stressa Incorporated031377428MANUFACTURE(53882-001)

Revised: 12/2012
Document Id: 6e022f69-388e-49e9-867e-78a7e57c8ede
Set id: 96372b6d-8346-480a-b292-958dd874b158
Version: 1
Effective Time: 20121205
 
Stressa Incorporated