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Berri-Freez Plus

Medically reviewed on August 23, 2017

Dosage form: gel
Ingredients: MENTHOL 4.52g in 113g, CAMPHOR (SYNTHETIC) 0.226g in 113g, METHYL SALICYLATE 9.04g in 113g
Labeler: Geritrex LLC
NDC Code: 54162-008

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 Plus

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.

  • For External Use Only
  • Use only as directed
  • Avoid contact with eyes
  • Do not bandage tightly
  • Do not apply to wounds or damaged skin
  • Do not use with 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.

Keep out of reach of children. If swallowed, get medical attention or contact the Poison Control Center immediately.

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

  • 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 

  • Keep container tightly closed
  • Keep away from heat and open flame
  • Store at room temperature 15°-30°C (59°-86°F)

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

BERRI-FREEZ PLUS 
menthol, camphor, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-008
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4.52 g  in 113 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.226 g  in 113 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE9.04 g  in 113 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
ALOE VERA LEAF 
ARNICA MONTANA 
CALENDULA ARVENSIS LEAF 
PEG-40 CASTOR OIL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
DMDM HYDANTOIN 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
METHYLPARABEN 
PROPYLPARABEN 
THYME 
TRIETHANOLAMINE BENZOATE 
WATER 
GREEN TEA LEAF 
SILICON DIOXIDE 
TEA TREE OIL 
Packaging
#Item CodePackage Description
1NDC:54162-008-04113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2015
Labeler - Geritrex LLC (112796248)

 
Geritrex LLC

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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