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Berri-Freez by Geritrex LLC

Medically reviewed on October 20, 2016

Dosage form: gel
Ingredients: MENTHOL 5.085g in 113g
Labeler: Geritrex LLC
NDC Code: 54162-009

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Berri-Freez

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

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

Keep away from heat and open flame

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

Keep out of reach of children if swallowed, get medical

attention or contact the poison control center immediately



BERRI-FREEZ 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-009
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5.085 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
CARBOMER 940 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
DMDM HYDANTOIN 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
SILICON DIOXIDE 
THYME 
TROLAMINE 
WATER 
Packaging
#Item CodePackage Description
1NDC:54162-009-04113 g in 1 TUBE
2NDC:54162-009-16454 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2015
Labeler - Geritrex LLC (112796248)
Registrant - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-009)

 
Geritrex LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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