FDA.reportPublic FDA data

PAIN GOODBYE AQUEOUS PATCH

Manufacturer
Austin Biotechnology Inc
Effective date
2013-10-10
Label type
HUMAN OTC DRUG LABEL
Version
2986
Source
full-release
Hydrated at
2026-05-31 22:37:10

Label at a glance#

ProductPAIN GOODBYE AQUEOUS PATCH
Active ingredientMETHYL SALICYLATE, 2-(L-MENTHOXY)ETHANOL
Label structure11 sections

Indications and uses

Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily. Bandage will remain effective after 24 hours and will be even more effective when using after a bath. Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal. Other Information: Keep container tightly closed. Once opened, fold the opening and k...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate   50 mg

L-Methenol            80 mg

PURPOSE

OTC - PURPOSE SECTION

Methyl Salucylate   External Analgesic

L-Methenol             External Analgesic

USES

INDICATIONS & USAGE SECTION

Uses for the temporary relief of minor aches, and points of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

WARNINGS

WARNINGS SECTION

For External Use Only. Do not use on wounds, on infected or damaged skin.

Stop use and ask a doctor if

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or consult a poison control center right away.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Condition worsens.

Symptom clears up and occurs again within a few days.

Symptom persists for more than 7 days.

Nausea, vomitting, abdominal discomfort, diarrhea, or skin rash occurs.

Excessive irritation of the skin develops.

Stop use and ask a doctor if

OTC - WHEN USING SECTION

Avoid contact with eyes or mucous membranes.

Do not bandage tightly.

When using for pain of arthritis:

In conditions affecting children under 12 years of age

If red nose is present

If pain persists for more than 10 days

WARNINGS

OTC - ASK DOCTOR SECTION

For children under 12 years of age, do not  use, consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 12 years of age and older; Remove the clear film backing and apply to the sore area of skin. Use not than 3 times daily.

Bandage will remain effective after 24 hours and will be even more effective when using after a bath.

Do not apply to extremely hairy skin. Highly adhesive bandage may hurt skin upon removal.

Other Information:

Keep container tightly closed. Once opened, fold the opening and keep pressed. Close with a clip.

Store at room temperature.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Gelatin, Myrrhm, Sesame Oil, Water and Zinc Oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton.jpgcarton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15667-7396-52019-11-27C16284748780-19855e2a2-3bd0-60a7-e053-dbdaa90a05bdPAIN GOODBYE AQUEOUS BALM PATCH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15667-7396-3PAIN GOODBYE AQUEOUS PATCH1000 mg in 1 BAGPATCH10002986
15667-7396-5PAIN GOODBYE AQUEOUS PATCH5 in 1 BAGPATCH52986

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15667-7396PAIN GOODBYE AQUEOUS PATCH (METHYL SALICYLATE) PATCH [AUSTIN BIOTECHNOLOGY INC]2986Legacy NDC, 2 package rows20131010_0e8b325d-4b41-4f9f-a778-b9b5d1c8525f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
2-(L-MENTHOXY)ETHANOLACTIVE INGREDIENT5ZWW23169H2986
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y2986
2-(L-MENTHOXY)ETHANOLACTIVE MOIETY5ZWW23169H2986
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ2986
GELATININACTIVE INGREDIENT2G86QN327L2986
MYRRHINACTIVE INGREDIENTJC71GJ1F3L2986
SESAME OILINACTIVE INGREDIENTQX10HYY4QV2986
WATERINACTIVE INGREDIENT059QF0KO0R2986
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54Z2986

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15667-739615667-7396-3, 15667-7396-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
2-(L-MENTHOXY)ETHANOL5ZWW23169HACTIB
GELATIN2G86QN327LIACT
MYRRHJC71GJ1F3LIACT
SESAME OILQX10HYY4QVIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZIACT

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 1 · 52 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION, SUSPENSION / SUBCUTANEOUSNAExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / SUBLINGUAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSUPPOSITORY / RECTAL375 mgExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR2 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / NASAL50 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LWAFER / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LELIXIR / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / RESPIRATORY (INHALATION)100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTILLE / ORAL143 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, EXTENDED RELEASE / ORAL239 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, EXTENDED RELEASE / ORAL1229 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZINJECTION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / RESPIRATORY (INHALATION)3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, SUSPENSION / INTRAMUSCULAR1.3 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRACAVITARY0.05 mlExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / SUBCUTANEOUS16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED / ORAL288 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYSTEM / TOPICAL1050 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZLOTION / TOPICAL16 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / PERIODONTAL3.44 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, COATED / ORAL42.12 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, DELAYED RELEASE / ORAL1791 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAMUSCULAR16 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, FILM COATED / ORAL57 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii candidate
44 equally ranked IID candidates
ZINC OXIDEZINC OXIDESOI2LOH54ZSOLUTION / INTRAVENOUS3.11 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LSYRUP / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION / INTRAVENOUS20 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED PELLETS / ORAL65 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
SESAME OILSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS14 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LDROPS / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / SUBLINGUAL13 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, ORALLY DISINTEGRATING / ORAL120 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / INTRAVENOUS34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
44 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
8c3ae600-4511-4868-a9bd-848f707e7f870e8b325d-4b41-4f9f-a778-b9b5d1c8525f2013-10-10WarningsExact identifier
spl id: 8c3ae600-4511-4868-a9bd-848f707e7f87
spl set id: 0e8b325d-4b41-4f9f-a778-b9b5d1c8525f

Reported adverse events (FAERS/openFDA)#

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