FDA.reportPublic FDA data

Large Medicate Relief Patches

Manufacturer
Amerisource Bergen | Foshan Aqua Gel Biotech Co.,Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:28:10

Label at a glance#

ProductLarge Medicate Relief Patches
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Dosage and administration

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application. Children under 12 years of age: consult physician. Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer For temporary relief of minor ach...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% .......Topical Analgesic

For External Use Only

WARNINGS SECTION

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use

Do not use:

OTC - DO NOT USE SECTION

  • On wounds or damaged skin
  • With a heating pad
  • If you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • Use only as directed
  • Avoid contact with eyes, mucous membranes or rashes
  • Do not bandage tightly
  • Do not use at the same time as other topical analgesics
  • Dispose of used patch in manner that keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

OTC - STOP USE SECTION

  • If rash, itching or excessive skin irritation develops
  • If condition worsens
  • if symptoms last more than 7 days or clear up and occur again with a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Uses

OTC - PURPOSE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains.

Pain Relief Patch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box of 6
NDC:46122-645-130
Box of 6Box of 6

DIST. BY
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
www.mygnp.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN4
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD4
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-645-132022-12-16C16284748780-1d6a99b39-dc60-a426-e053-dadaa90af4c2Good Neighbor Medicated Relief Patches
46122-645-132022-01-28C16284748780-1d6a99b39-dc60-a426-e053-dadaa90af4c2Good Neighbor Medicated Relief Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-645-13Large Medicate Relief Patches6 in 1 BOXPATCH64
46122-645-13Large Medicate Relief Patches9 g in 1 PATCHPATCH94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-645-13EA - Each46122-645081cb258-fbd2-4a2e-a60f-05815263979912021-09-07

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-64546122-645-13

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
HYDROGENATED POLYDECENE (550 MW)U333RI6EB7IACT
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)255PIF62MSIACT
LIQUID PETROLEUM6ZAE7X688JIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

Source Document#

Source XML

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
Large Medicate Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergena7d5f89b-59b9-4603-99aa-273b85be813e2025-12-22WarningsExact identifier
ndc (package): 46122-645-13
ndc (product): 46122-645
ndc11 (package): 46122064513
spl id: 4694b735-e565-5a62-e063-6394a90a64e3
spl set id: a7d5f89b-59b9-4603-99aa-273b85be813e

Reported adverse events (FAERS/openFDA)#

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