STRESSA BACK AND NECK PAIN RELIEVING- menthol oil

Stressa Back and Neck Pain Relieving by

Drug Labeling and Warnings

Stressa Back and Neck Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Stressa Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Menthol 1.25%

Purpose

topical analgesic

Uses

For the temporary relief of pain associated with

• simple backache
• strains
• bruises
• sprains

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)

INGREDIENTS AND APPEARANCE

STRESSA BACK AND NECK PAIN RELIEVING 
menthol oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53882-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A)	Menthol	1 g  in 93 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	ORANGE (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53882-002-01	60 mL in 1 BOTTLE, PLASTIC
2	NDC: 53882-002-02	118 mL in 1 BOTTLE, PLASTIC
3	NDC: 53882-002-03	240 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	08/01/2014

Labeler - Stressa Incorporated (031377428)

Establishment
Name	Address	ID/FEI	Business Operations
Stressa Incorporated		031377428	MANUFACTURE(53882-002)