Fordagel Kit by Medcore LLC Fordagel Kit Drug Facts

Fordagel Kit by

Drug Labeling and Warnings

Fordagel Kit by is a Otc medication manufactured, distributed, or labeled by Medcore LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FORDAGEL KIT- neuracin topical analgesic gel gel 
Medcore LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Fordagel Kit
Drug Facts

Active Ingredients (in each gram)

Camphor 4%

Menthol 10%

Methyl Salicylate 30%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain associated with:

• simple backache
• muscle strains
• bruises
• muscle sprains

Warnings

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

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

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

Children under 12 years of age: ask a doctor.

Inactive Ingredients

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

Questions? 908-280-2269

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].

FORDAGEL KIT 
neuracin topical analgesic gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82461-650
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82461-650-57	56.7 g in 1 CARTON; Type 0: Not a Combination Product	05/04/2022	09/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/04/2022	09/19/2022

Labeler - Medcore LLC (069802634)

Revised: 9/2022

Document Id: 372a64a3-5fd7-470c-9810-fac1f9ada542

34390-5

Set id: 156eccfa-b515-4e69-9c72-2239dfcab5a1

Version: 3

Effective Time: 20220919