Berri-freez Plus
FDA Label NDC 54162-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Berri-freez Plus (NDC 54162-008). 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 drug facts, uses, dosage & administration, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient: . . . . . . . . . . . . Purpose

Methyl Salicylate 8%        Pain Relief

Menthol USP 4%              Pain Relief
Camphor USP 0.2%         Pain Relief

Uses

For the temporary relief of minor aches and
pains of muscles and joints associated with simple
backache, arthritis, strains, bruises, and sprains.

Dosage & Administration

  • Apply to affected area not more than 3 to 4 times daily

Indications & Usage

  • For adults & children 2 years of age and older
  • Children under 2 years of age, consult a doctor
  • Cleanse and dry skin
  • Apply to affected area not more than 3 to 4 times daily
  • May be used with wet or dry bandages in conjunction with ice packs 

Inactive Ingredient

Aloe, Arnica, Calendula, Carbomers, FD&C Blue #1, FD&C Yellow #5, DMDM Hydantoin, Glycerine, Green Tea, L. Paraguariensis, Isopropyl Alcohol, Methyl & Propyl Paraben, PEG-40, Hydrogenated Castor Oil, Silicone Dioxide, Tea Tree Oil, Thyme, Triethanolamine, Water

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