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Berri-Freez by Geritrex LLC

Medically reviewed on August 12, 2016

Dosage form: spray
Ingredients: MENTHOL 11.8g in 118mL
Labeler: Geritrex LLC
NDC Code: 54162-002

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

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.

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

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

If pregnant or breastfeeding ask a health professional before use.

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

BERRI-FREEZ 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL11.8 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA 
CALENDULA OFFICINALIS FLOWER 
ECHINACEA, UNSPECIFIED 
CHAMOMILE 
WHITE TEA 
ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPER BERRY 
WATER 
Packaging
#Item CodePackage Description
1NDC:54162-002-04118 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-002)

 
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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