FDA.reportPublic FDA data

Pain Cream

Manufacturer
Eagle Labs Inc. | Eagle Labs Inc
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:11:11

Label at a glance#

ProductPain Cream
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

For Temporary relief of aches and pains of muscles and joints associated with arthritis, bachaches, strains, or sprains.

Dosage and administration

Adults and children over 12 years old: Apply to affected area - do not apply more than 4 times adaily: Children 12 years or younger: Consult a doctor

Storage and handling

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 6%

Camphor 5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For Temporary relief of aches and pains of muscles and joints associated with arthritis, bachaches, strains, or sprains.

WARNINGS:

WARNINGS SECTION

For external use only. Do not use if safety seal is damaged or missing.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Use only as directed: Avoid contact with eyes or mucous membranes: Do not apply directly to wounds or damaged skin: Do no use in combination with other ointments, creams, or sprays: Wash hands with cool water after each use: Do not sue with a heat pad or device.

Stop Usage immediately and as a doctor if:

OTC - STOP USE SECTION

Condition worsens or symptoms persist for more than 7 days.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, get medical help, or contact poison control center immediately: 1-800-222-1222

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years old: Apply to affected area - do not apply more than 4 times adaily: Children 12 years or younger: Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Bis-Vinyl Dimethicone/Dimthicone Copolymer, C13-C14 Isoparaffin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Glycol Stearate, Jojoba Oil, Laureth-7, Lavender Oil, Phenoxyethanol, Polyarylamide, Shea Butter, Simethicone, Sodium Acrylate/Sodium Acrylol Dimethyl Taurate Copolymer, Spearmint Oil, Water.

INSTA EAZE: RUB THE PAIN AWAY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Insta Eaze Rub The Pain AwayInsta Eaze Rub The Pain Away

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2610119camphor 5 % / menthol 6 % Topical CreamPSN3
2610119camphor 50 MG/ML / menthol 60 MG/ML Topical CreamSCD3
2610119camphor 5 % / menthol 6 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79804-260-022024-04-16C16284748780-11030e365-1983-111a-e063-dadaa90a10e2Pain Cream
79804-260-022024-01-30C16284748780-11030e365-1983-111a-e063-dadaa90a10e2Pain Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79804-260-02Pain Cream59 g in 1 PACKAGECREAM593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79804-260PAIN CREAM (ANALGESIC) CREAM [EAGLE LABS INC.]3Legacy NDC, 1 package rows20240418_ddc04680-896d-4664-b010-359d1b1107df.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79804-26079804-260-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
LAURETH-7Z95S6G8201IACT
LAVENDER OILZBP1YXW0H8IACT
SPEARMINT OILC3M81465G5IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
DIMETHICONE92RU3N3Y1OIACT
GLYCOL STEARATE0324G66D0EIACT
JOJOBA OIL724GKU717MIACT

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
16235cd7-a286-2c96-e063-6294a90a806bddc04680-896d-4664-b010-359d1b1107df2024-04-15WarningsExact identifier
spl id: 16235cd7-a286-2c96-e063-6294a90a806b
spl set id: ddc04680-896d-4664-b010-359d1b1107df

Reported adverse events (FAERS/openFDA)#

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