COOLEXA- camphor, menthol, methyl salicylate cream

Coolexa by

Drug Labeling and Warnings

Coolexa by is a Otc medication manufactured, distributed, or labeled by Rising Pharma Holdings, Inc., Elysium Pharmaceuticals Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Camphor 4%	Topical analgesic
Menthol 10%	Topical analgesic
Methyl Salicylate 30%	Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• strains
• bruises
• sprains

Warnings

For external use only.

Do not use

• on wounds or damaged skin
• with a heating pad or apply external heat
• on a child under 12 years of age with arthritis-like conditions

Ask a doctor before use if you have redness over the affected area

When using this product

• avoid contact with eyes or mucous membranes
• do not bandage tightly

Stop use and ask a doctor if

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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: ask a doctor

Other Information

• store at 20° to 25°C (68° to 77°F)
• Lot No. & Exp Date: See box or crimp of tube

Inactive Ingredients

Carbomer, disodium edetate, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, trolamine, water.

Questions and comments?

Call 1-844-474-7464

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CoolexaTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/1362

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

CoolexaTM

Camphor, Menthol, Methyl Salicylate

4%, 10%, 30%

Topical analgesic cream

ULTRA STRENGTH

Net Wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

COOLEXA 
camphor, menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57237-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
LANOLIN (UNII: 7EV65EAW6H)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57237-351-57	1 in 1 CARTON	11/06/2025
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 57237-351-13	1 in 1 CARTON	11/06/2025
2		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	11/06/2025

Labeler - Rising Pharma Holdings, Inc. (116880195)

Registrant - Elysium Pharmaceuticals Ltd (915664486)

Establishment
Name	Address	ID/FEI	Business Operations
Elysium Pharmaceuticals Ltd		915664486	manufacture(57237-351) , analysis(57237-351) , label(57237-351) , pack(57237-351)