Ice Cold Analgesic
FDA Label NDC 70201-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by North & South Wholesalers Llc for the product Ice Cold Analgesic (NDC 70201-005). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Menthol             1.25%

Otc - Purpose

Purpose

Topical Analgesic

Indications & Usage

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
  • arthritis
  • simple backache
  • strains
  • bruises
  • sports injuries
  • sprains
  • provides cooling penetrating relife

Warnings

Warnings

For external use only

Otc - Do Not Use

Do not use

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

Otc - When Using

When using this product

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

Otc - Stop Use

Stop use and ask a doctor if

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children

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

Dosage & Administration

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

Other information

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

Inactive Ingredient

Inactive Ingredients

benzyl alcohol, BHT, camphor, carbopol, disodium EDTA, FD&C blue no.1, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, sodium hydroxide, water.

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

ICE COLD ANALGESIC GEL

Topical Analgesic

NET WT.8 OZ (227g)

Label (Ice Cold Gel)

Label (Ice Cold Gel)

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