Aurorae Healing Pain Relieving Roll-On

Manufacturer
Ingui Design, LLC
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:05:37

Label at a glance#

ProductAurorae Healing Pain Relieving Roll-On
Active ingredientMENTHOL
Label structure6 sections

Indications and uses

for temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Dosage and administration

Apply directly to affected area. Do not use more than four times per day.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10.00%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor aches and pains associated with simple backache, arthritis, bruises and sprains.

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes
  • Do not apply to open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed consult physician.

Do not bandage tightly.

If pregnant or breast feeding consult physician prior to use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply directly to affected area. Do not use more than four times per day.

Other ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gell, Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Flower Extract, Cetyl Alcohol, Ethylhexylglycerin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Methyl Salicylate, PEG-8, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aurorae Healing Pain Relieving Roll OnAurorae Healing Pain Relieving Roll On

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H81
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69582-59069582-590-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 154 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSWAB / TOPICAL5250 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCREAM / TOPICAL214 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSPRAY / TOPICAL3665 mgExact identifier — unii candidate
18 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / TOPICAL11100 mgExact identifier — unii candidate
36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / VAGINAL30 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSPRAY / TOPICAL7 mgExact identifier — unii candidate
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLOTION / TOPICAL360 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSHAMPOO / TOPICAL3.7 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, COATED / ORAL0.25 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, DELAYED RELEASE PELLETS / ORAL99 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET / SUBLINGUAL1.1 mgExact identifier — unii candidate
42 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSFILM, EXTENDED RELEASE / TRANSDERMAL20.4 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQEMULSION / TOPICAL1.2 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOIL / AURICULAR (OTIC)36 mgExact identifier — unii candidate
18 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL, METERED / TRANSDERMAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION/ DROPS / OPHTHALMIC1 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / VAGINAL0.2 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
LAVENDER OILLAVENDER OILZBP1YXW0H8GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSFILM / TRANSDERMAL58.08 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQOINTMENT / TOPICAL1950 mgExact identifier — unii candidate
36 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUSPENSION / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JOINTMENT / TOPICAL14 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / DENTAL1.47 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
071d9078-098c-8494-e063-6394a90a27554875576f-d27f-4101-b191-26dd4399ef0d2023-10-07WarningsExact identifier
spl set id: 4875576f-d27f-4101-b191-26dd4399ef0d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.