FDA.reportPublic FDA data

Berri-Freez

Manufacturer
Geritrex LLC
Effective date
2016-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:48

Label at a glance#

ProductBerri-Freez
Active ingredientMENTHOL
Label structure10 sections

Indications and 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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:    

Menthol USP 10%

Purpose:

OTC - PURPOSE SECTION

Cooling Pain Reliever

Uses:

INDICATIONS & USAGE SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

For external use only. Keep out of reach of children.

WARNINGS SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

Arnica Montana, Calendula, Chamomile, Echinacea, Ethanol, ILEX Paragurenis, Isopropyl Myristate, Juniper Berry, Water, White Tea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
667889menthol 10 % Topical SprayPSN1
667889menthol 100 MG/ML Topical SpraySCD1
667889menthol 10 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-002-042020-01-31C16284748780-19d75b9d0-cfb2-f424-e053-dadaa90a57ceBerri-Freez

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-002-04Berri-Freez118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-002BERRI-FREEZ (MENTHOL) SPRAY [GERITREX LLC]1Legacy NDC, 1 package rows20160816_4c1e9e71-49f7-4a2c-a9e7-3496f6278f0c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-002-04ML - Milliliter54162-002f9979ca3-62d6-4a3b-bd2d-bc080cda7a7712016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-00254162-002-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ARNICA MONTANAO80TY208ZWIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ECHINACEA, UNSPECIFIED4N9P6CC1DXIACT
CHAMOMILEFGL3685T2XIACT
WHITE TEAO0M3396E09IACT
ALCOHOL3K9958V90MIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
JUNIPER BERRYO84B5194RLIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b241791-cd3a-4b8b-b66a-61bb758bcf474c1e9e71-49f7-4a2c-a9e7-3496f6278f0c2016-08-12WarningsExact identifier
spl id: 4b241791-cd3a-4b8b-b66a-61bb758bcf47
spl set id: 4c1e9e71-49f7-4a2c-a9e7-3496f6278f0c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.