Analgesic

Manufacturer
Safetec of America, Inc. | Safetec of America, Inc
Effective date
2018-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:45

Label at a glance#

ProductAnalgesic
Active ingredientmenthol
Label structure8 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints.

Dosage and administration

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

USP Menthol 7%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles and joints.

Warnings

WARNINGS SECTION

For external use only.

Flammable.

Keep away from flame.

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. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Will not stain clothing. For children under 2 years of age, consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil, Xanthan Gum.

Principal Display Panel - Pain Relief Roll-On Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61010-XXXX-X

Safetec

PAIN
RELIEF
ROLL-ON

MEDICATED FAST-ACTING

For temporary relief of
minor aches and pains

3 fl. oz. (88 ml)

Reorder no. 58001

Principal Display Panel - Pain Relief Roll-On Bottle Label
Principal Display Panel - Pain Relief Roll-On Bottle Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-8202-0Analgesic0.088 L in 1 BOTTLE, WITH APPLICATORGEL0.0881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-8202ANALGESIC (MENTHOL) GEL [SAFETEC OF AMERICA, INC.]1Current NDC, Legacy NDC, 1 package rows20180906_a90266d4-1e71-4805-aeca-6f8ed45135bb.zip

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
61010-820261010-8202-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
ndc (package): 61010-8202-0
ndc (product): 61010-8202
ndc11 (package): 61010820200
spl id: a4cdd5eb-fbda-4f99-b737-452a1487adfd
spl set id: a90266d4-1e71-4805-aeca-6f8ed45135bb

Reported adverse events (FAERS/openFDA)#

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