Universal Ice Cold Analgesic Gel
FDA Label NDC 52000-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Center Llc for the product Universal Ice Cold Analgesic (NDC 52000-105). 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
  • provides cooling penetrating relief

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 right away

Directions

  • clean affected area before applying product
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other Information

  • store at controlled room temperature 20 to 25oC (68 to 77oF in a tightly closed container
  • do not use, pour, spill or store near heat or open flame

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 (227 GRAM)

Principal Display Panel (Ice Cold Gel)

Principal Display Panel (Ice Cold Gel)




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