Flexilon

Manufacturer
Topical Pharmaceuticals Inc.
Effective date
2021-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:55:52

Label at a glance#

ProductFlexilon
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with:  • simple backache • arthritis • strains • bruises • sprains

Dosage and administration

• 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: consult a doctor.

Storage and handling

store at 20° - 25°C (68° - 77°F) Do not purchase if outer seal is broken.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints associated with: 

• simple backache • arthritis • strains • bruises • sprains

Warnings

WARNINGS SECTION

For external use only
Do not use • on wounds or damaged, broken or irritated skin • with a heating pad 

When using this product
• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if • condition worsens 

• you have redness over the affected area 

• symptoms persist for more than 7 days or symptoms clear up and occur again within a few days
• excessive skin irritation occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

• 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: consult a doctor.

Other Information

STORAGE AND HANDLING SECTION

store at 20° - 25°C (68° - 77°F)

Do not purchase if outer seal is broken.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, cetearyl alcohol, D.I.water, FD&C Blue no. 1, FD&C Yellow no.5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

SPL UNCLASSIFIED SECTION

SEMPRAE™

ARTHRITIS RELIEF

• Muscle Aches
• Joint Pain Arthritis
• Back Pain Knee Pain

If muscles or joint aches and pain slows you down, we would like to introduce you to Flexilon Arthritis Cream.
Flexilon is a fast-acting and powerful arthritis cream, formulated to target the joints where arthritis resides and soothe the pain for long lasting relief.
Flexilon over-the-counter medication cream provides ultra strength, deeper penetrating pain relief in muscles and joints.

Manufactured for: SEMPRAE™

Semprae Laboratories, Inc.

Englewood, CO 80112

For comments or questions and to place an order,
Call us at 1-800-996-5122 or visit us at www.myflexilon.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15478-10115478-101-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
7ebff913-78f6-4ffc-8e38-fda65604b7978e531f12-9d8a-4fed-984a-0262848a45a02021-01-19WarningsExact identifier
spl id: 7ebff913-78f6-4ffc-8e38-fda65604b797
spl set id: 8e531f12-9d8a-4fed-984a-0262848a45a0

Reported adverse events (FAERS/openFDA)#

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