Universal Ice Cold Analgesic
FDA Label NDC 47046-159

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Anicare Pharmaceuticals Pvt. Ltd. for the product Universal Ice Cold Analgesic (NDC 47046-159). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of the reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 1.25%

Purpose

Topical Analgesic

Uses

Temporary relieves of minor aches and pains in muscles and joints associated with

  • arthritis
  • simple backache
  • strains
  • bruises
  • sports injuries
  • sprains

Warnings

For external use only

Do not use

  • with other topical pain relievers
  • with heating pads or heating devices

When Using This Product

  • do not use in or near the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask Doctor If

  • condition worsens
  • symptoms last more than 7 days or clean up and occur again within a few days
  • redness or irritation develops

If Pregnant Or Breast-Feeding,

  • ask a health professional before use

Keep Out Of The Reach Of Children

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

Directions

  • clean affected area before applying products
  • adults and children 2 years of age and older
  • apply to affected area not more than 3 to 4 times daily.

Inactive Ingredients

Water, Propylene glycol, Isopropyl alcohol, Carbomer, Sodium hydroxide, Benzyl alcohol, Edetate Disodium, Butylated hydroxytoluene, Camphor, Fd&c Blue No. 1

Principal Display Panel

ICE COLD
ANALGESIC GEL
8 FL.OZ (237 ml)

Principal Display Panel (Ice Cold Gel Tube)

Principal Display Panel (Ice Cold Gel Tube)




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