Stressa Back And Neck Pain Relieving
FDA Label NDC 53882-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stressa Incorporated for the product Stressa Back And Neck Pain Relieving (NDC 53882-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Menthol 1.25%

Purpose

topical analgesic

Uses

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

  • simple backache
  • strains
  • bruises
  • sprains

Warnings

For external use only.

Otc - Do Not Use

Do not apply to wounds or damaged skin

Otc - When Using

When using this product

  • avoid contact with eyes
  • do not bandage tightly

Otc - Stop Use

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

Otc - Keep Out Of Reach Of Children

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)

Principal Display Panel (43g Jar Carton)

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