FDA Label for Berri-freez

View Indications, Usage & Precautions

Berri-freez Product Label

The following document was submitted to the FDA by the labeler of this product Geritrex Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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






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