FDA.reportPublic FDA data

AMPlify Relief MM

Manufacturer
International Brand Management, LLC
Effective date
2017-03-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:49:15

Label at a glance#

ProductAMPlify Relief MM
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Methyl Salicylate....30.00%

Menthol.................10.00%

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Topical Analgesic

INDICATIONS & USAGE SECTION

Uses: temporarily relieves the minor aches and pains of muscles and joints associated with:

-simple backache  -arthritis   -strains   -bruises   -sprains

WARNINGS SECTION

Warnings:

For external use only

Do not use:

-on wounds or damaged skin     -with a heating pad

-on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

OTC - WHEN USING SECTION

When using this product:

-avoid contact with eyes or mucous membranes

-do not bandage tightly

OTC - STOP USE SECTION

Stop use and ask a doctor if:

-condition worsens or symptoms persist for more than 7 days

-symptoms clear up and occur again within a few days

-excessive skin irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or

contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION SECTION

Directions:

-use only as directed

-adults and children 12 years of age and older:

apply to affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),

Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Cannabis

Sativa (Hemp) Seed Oil, Cetearyl Olivate, Cetyl Alcohol, Chondrotin Sulfate, Gluconolactone,

Glucosamine Sulfate, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Magnesium

Sulfate, Methylsulfonylmethane (MSM), Sodium Benzoate, Sodium Laurylglucosides

Hydroxypropylsulfonate, Sorbitan Olivate, Tapioca Starch, Xanthan Gum, Zemea (Corn)

Propanediol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN4
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD4
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-019-012020-01-31C16284748780-19d75b9d1-0507-f424-e053-dadaa90a57ceef713a9f-4210-454c-8349-4f5e8b52000d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-019-01AMPlify Relief MM1 in 1 CARTONCREAM14
69837-019-02AMPlify Relief MM118 g in 1 TUBECREAM1184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-019AMPLIFY RELIEF MM (METHYL SALICYLATE, MENTHOL) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]4Legacy NDC, 2 package rows20170314_ef713a9f-4210-454c-8349-4f5e8b52000d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69837-019-01GM - Gram69837-0191e8ada3b-d342-48b2-a84e-c5dca3bfe5d512017-09-11

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69837-01969837-019-02, 69837-019-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
Cetearyl Olivate58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
CHONDROITIN SULFATE (SHARK)2ZAJ1K50XHIACT
GLUCONOLACTONEWQ29KQ9POTIACT
Glucosamine Sulfate1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SUNFLOWER OIL3W1JG795YIIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN OLIVATEMDL271E3GRIACT
STARCH, TAPIOCA24SC3U704IIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT

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
6b074006-0212-4147-a5fa-2b1b85b1fb1fef713a9f-4210-454c-8349-4f5e8b52000d2017-03-13WarningsExact identifier
spl id: 6b074006-0212-4147-a5fa-2b1b85b1fb1f
spl set id: ef713a9f-4210-454c-8349-4f5e8b52000d

Reported adverse events (FAERS/openFDA)#

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