Coolexa Cream
FDA Label NDC 57237-351

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Coolexa (NDC 57237-351). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, otc - ask doctor, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

Otc - Purpose

Active IngredientsPurpose
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

Otc - Ask Doctor

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

Otc - Keep Out Of Reach Of Children

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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