Hot Ice Soothing Analgesic
FDA Label NDC 52271-159

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Care Distributors Llc for the product Hot Ice Soothing Analgesic (NDC 52271-159). 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, do not use, when using this product, stop use and ask doctor if, keep out of 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%

Camphor 0.5%   

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains in muscles and joins associated with

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

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 eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask Doctor If

  • condition worsen
  • symptoms last more than 7 days or clear up and occurs again with a few days
  • redness or irritation develops

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

Keep Out Of Reach Of Children.

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

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. 

Inactive Ingredients

Benzyl alcohol, butylated hyderoxy toluene, carbopol, colour brilliant blue, creasmer RH 40, disodium Edta, isopropyl alcohol, propylene glycol, purified water, sodium hydroxide

Principal Display Panel

FamilyCare
ICE
COLD
ANALGESIC GEL
NET WT. 8 OZ. (227 g)

Principal Display Panelfamilycare Ice Cold Analgesic Gel (Ice Cold Analgesic Gel 01)

Principal Display Panelfamilycare Ice Cold Analgesic Gel (Ice Cold Analgesic Gel 01)

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