Freeze Ease Gel
FDA Label NDC 87843-312

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 (NDC 87843-312). 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, do not use :, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Warnings

→ Do Not Use :

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel

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.
Read all warnings and directions before use.
Test first on small area of skin.
Keep out of the reach of children.

Do Not Use :

On wounds or damaged skin

When Using This Product

You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
Avoid contact with the eyes, lips, nose and mucous membranes
Do not tightly wrap or bandage the treated area
Do not apply heat to the treated area immediately before or after use

Stop Use And Ask A Doctor If

Condition worsens or does not improve after regular use

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.

Other Information

Excursions permitted to 15°-30°C (59°-86°F).
See USP Controlled Room Temperature.

Inactive Ingredients

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