Miracle Ice
FDA Label NDC 60691-116

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fdn Enterprises,llc for the product Miracle Ice (NDC 60691-116). 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, otc - do not use, otc - when using, otc - ask doctor, 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

Other

Drug Facts

Distributed by:
FDN Enterprises, LLC.
Opa Locka, FL 33054

Otc - Purpose

Active IngredientPurpose
Menthol 1%Topical analgesic
Camphor 0.5%Topical analgesic

Uses

  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • arthritis
    • simple backache
    • strains
    • bruises
    • sport injuries
    • sprains

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 - Ask Doctor

Stop use and ask a doctor if

  • condition worsens
  • symptoms last more than 7 days or clear 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 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 room temperature 59°-86°F (15°-30°C).
  • Keep jar tightly closed and away from open heat or flame

Inactive Ingredients

Aqua, Propylene Glycol, Carbomer, Methyl Salicylate, Sodium Hydroxide, Sodium Methyl Paraben, Sodium Propyle Paraben, CI 14720, CI 16185, CI 42090

Principal Display Panel - 227 G Jar Label

FDN Medical®
MIRACLE
ICE

ULTRA STRENGTH

ANALGESIC GEL

NET WT. 8 OZ (227 g)

Principal Display Panel (227 g Jar Label)

Principal Display Panel (227 g Jar Label)

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