Berri-freez
FDA Label NDC 54162-002

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 (NDC 54162-002). 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 otc - active ingredient, purpose:, uses:, warnings:, warnings, otc - stop use, otc - pregnancy or breast feeding, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient:    

Menthol USP 10%

Purpose:

Cooling Pain Reliever

Uses:

Temporary relief of minor aches and pains related to:

  • Back, Shoulder, and Neck strains
  • Ankle, Knee, Hip and Elbow joint discomfort
  • Muscle sprains and strains
  • Arthritis

Warnings:

For external use only. Keep out of reach of children.

Warnings

Flammable: Keep away from excessive heat or open flame. If accidnetally ingested, get medical help or contact a Poison Control Center immediately.

When using this Product:

Avoid contact with the eyes or mucous membranes

Do not apply to wounds or damaged skin

Do not apply to irritated skin or if excessive irritation develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device

Otc - Stop Use

Stop Use and ask a Doctor if: Condition worsens, or if symptoms persist for more than 7 days, or clear up or reoccur

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding ask a health professional before use.

Dosage & Administration

Adults and children 12 years of age and older:
1-2 sprays on the affected areas as needed but not more than 4 times daily; massage not necessary.

Inactive Ingredients:

Arnica Montana, Calendula, Chamomile, Echinacea, Ethanol, ILEX Paragurenis, Isopropyl Myristate, Juniper Berry, Water, White Tea

* Please review the disclaimer below.