Berri-freez
FDA Label NDC 54162-009

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 54162-009). 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, directions, dosage & administration, warnings, inactive ingredients, storage and handling, otc - keep out of reach of children, 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

Menthol USP 4.5% Pain Relieving Gel

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated with simple

backache, arthritis, strains, bruises, and sprains

Directions

For adults or 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

Keep container tightly closed

Dosage & Administration

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

Warnings

For External Use Only Use only as directed

Avoid contact with the eyes. Do not bandage tightly

Do not apply to wounds or damaged skin

Do not use with a heating pad

Stop use and ask a doctor if condition worsens or if

symptoms persist for more than 7 days or clear up

and occur again within a few days

Inactive Ingredients

Camphor, Carbomer 940, FD&C Blue#1, FD&C Yellow#5

DMDM Hydantoin, Glycerine, I.paraguariensis Extract, Isopropyl Alcohol

Methyl & Propyle paraben, Silicon Dioxide, Thyme, Triethanolamine, water

Storage And Handling

Keep away from heat and open flame

Store at room temperature 15°-30°C (59°-86°F)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children if swallowed, get medical

attention or contact the poison control center immediately

Package Label.Principal Display Panel

Package Label (Bfs4)

Package Label (Bfs4)



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