Fordagel Kit

Manufacturer
Medcore LLC
Effective date
2022-06-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:59:53

Label at a glance#

ProductFordagel Kit
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM
Label structure8 sections

Indications and uses

Temporarily relieves minor pain associated with: simple backache muscle strains bruises muscle sprains

Dosage and administration

Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with:

  • simple backache
  • muscle strains
  • bruises
  • muscle sprains

Warnings

WARNINGS SECTION

For External Use Only.

When using this product

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not bandage tightly or use heating pad
  • use only as directed

Stop and ask a doctor if

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again in a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help, or contact Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Carbomer, Pemulen, Polysorbate 80, Purified Water, Triethanolamine

Questions? 908-280-2269

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-650-57

RxOnly

For Topical Use Only

Fordagel
Topical Analgesic Gel

Neuracin Topical Analgesic Gel

(Camphor 4%; Menthol 10%;
Methyl Salicylate 30%)

2oz. (56.7 grams)

Alcohol Pads – (Sterile)

(70% isopropyl alcohol,-15 Prep Pads)

Keep this and all medication

out of reach of children.

See enclosed insert(s) for full prescribing information.

Storage: Store at 20º to 25ºC (68º to 77ºF)

[see USP Controlled Room Temperature].

labellabel

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-650-57EA - Each82461-650df9a16c1-749a-44c3-9b9a-343e0e933db112022-07-06

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-65082461-650-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
372a64a3-5fd7-470c-9810-fac1f9ada542156eccfa-b515-4e69-9c72-2239dfcab5a12022-09-19WarningsExact identifier
spl set id: 156eccfa-b515-4e69-9c72-2239dfcab5a1

Reported adverse events (FAERS/openFDA)#

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