FDA.reportPublic FDA data

Pain Relieving

Manufacturer
Safetec of America, Inc.
Effective date
2024-02-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:08:31

Label at a glance#

ProductPain Relieving
Active ingredientMENTHOL
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older : Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult a physician

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 4%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Use

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.

Warnings

WARNINGS SECTION

  • For external use only.

Flammable:Keep away from excessive heat or open flame.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:sensitive skin.

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do not apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or device

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding: Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help, contact a physician or Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
  • Children under 2 years of age:Consult a physician

Other Information

OTHER SAFETY INFORMATION

Store in a cool dry place.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leal), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, TocopheryI Acetate, Triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – 4 oz Pain Relieving Gel

Safetec®

Pain Relieving Gel

For Minor Aches & Pains of Muscles & Joints

Net Wt. 4 oz. (113.4g)

Reorder No. 58002

Manufactured for: Safetec of America, Inc.

Buffalo, NY 14215 I 1-800-456-7077

Made in IndiaKD/739

Principal Display Panel – 4 oz Pain Relieving Gel
Principal Display Panel – 4 oz Pain Relieving Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4403-12024-02-13C16284748780-11030e365-2c4c-111a-e063-dadaa90a10e261010-4403-1
61010-4403-12024-01-30C16284748780-11030e365-2c4c-111a-e063-dadaa90a10e261010-4403-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4403-1Pain Relieving113.4 g in 1 TUBEGEL113.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4403PAIN RELIEVING (MENTHOL) GEL [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240214_52ebf64d-095f-467e-bf51-dd8d33b58c7d.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-440361010-4403-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANAO80TY208ZWIACT
FRANKINCENSER9XLF1R1WMIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHYLAMINEVOU728O6AYIACT
MENTHOLL7T10EIP3AACTIB

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
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
ndc (package): 61010-4403-1
ndc (product): 61010-4403
ndc11 (package): 61010440301
spl id: 10aa8eb6-5d50-bea9-e063-6394a90a3623
spl set id: 52ebf64d-095f-467e-bf51-dd8d33b58c7d

Reported adverse events (FAERS/openFDA)#

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