Freeze Ease Roll-on Gel
FDA Label NDC 87843-311

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Global America Group Llc for the product Freeze Ease Roll-on (NDC 87843-311). 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, warnings, when using this product, stop use and ask a doctor if, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured for:

GAG
GLOBAL AMERICA
GROUP

Global America Group LLC
Brooklyn, NY 11201

Active Ingredient

Menthol 4%

Purpose

Topical analgesic

Warnings

For external use only.

Flammable: Keep away from excessive heat or open flame.

When Using This Product

  • use only as directed
  • avoid contact with the theeyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If

  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritis pain persists for more than 10 days, or rednessis present. allergic reaction occurs
  • If pregnant or breast-feeding, ask a health professional before use.
  • Keep out of reach of children. If swallowed, get medical help orcontact a Poison Control Center right away.

Directions

  • adults and children 5 years of age and older: apply externally to the affected area up to 3 to 4 times daily
  • children under 5 years of age: consult a physician
  • wash hands after use with cool water

Other Information

  • may be applied under occlusive dressing
  • store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Inactive Ingredients

GLYCERIN MONOSTEARATE ACETATE, ARNICA MONTANA FLOWER EXTRACT, GREEN TEA LEAF EXTRACT, LEMON OIL, ISOPROPYL ALCOHOL, CARBOMER, HOMOPOLYMER, BEESWAX, CASTOR OIL, ALPHA-TOCOPHEROL ACETATE, TROLAMINE, WATER.

Questions Or Comments?

646-457-4800

Principal Display Panel - 50 Ml Bottle Label

NDC:87843-311-50

FREEZE
EASE

MENTHOL 4% ROLL-ON

COOLING PAIN RELIEF GEL

50 mL

Principal Display Panel (50 mL Bottle Label)

Principal Display Panel (50 mL Bottle Label)

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