Amar Ice
FDA Label NDC 41499-123

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amar Remedies Limited for the product Amar Ice (NDC 41499-123). 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, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Menthol 2.5%

Purpose

Topical analgesic

Uses

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

Warnings

For external use only

Do Not Use

  • 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 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 in a cool place
  • keep lid tightly closed
  • do not use, pour, spill or store near heat or open flame

Inactive Ingredients

Water, Camphor, Carbopol, Methyl Paraben Sodium, Propyl Paraben Sodium, Wintergreen oil, Propylene Glycol, Phenoxy ethanol, ISO Propyl alcohol, Sodium Hydroxide, Cl 42090.

Principal Display Panel - 227 G Jar Label

Amar

ICE GEL

Net Wt 8 oz (227g)

Principal Display Panel (227 g Jar Label)

Principal Display Panel (227 g Jar Label)

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