FDA.reportPublic FDA data

Berri-Freez Plus

Manufacturer
Geritrex LLC
Effective date
2012-08-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:32

Label at a glance#

ProductBerri-Freez Plus
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC), METHYL SALICYLATE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Storage and handling

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

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: . . . . . . . . . . . . Purpose

Methyl Salicylate 8%        Pain Relief

Menthol USP 4%              Pain Relief
Camphor USP 0.2%         Pain Relief

Uses

OTC - PURPOSE SECTION

For the temporary relief of minor aches and
pains of muscles and joints associated with simple
backache, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

  • 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

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 and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INDICATIONS & USAGE SECTION

  • 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 

STORAGE AND HANDLING SECTION

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label of productlabel of product

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1729328Berri-Freez Plus (0.2 % / 4 % / 8 % ) Topical GelPSN1
1729323camphor 0.2 % / menthol 4 % / methyl salicylate 8 % Topical GelPSN1
1729328camphor 0.002 MG/MG / menthol 0.04 MG/MG / methyl salicylate 0.08 MG/MG Topical Gel [Berri-Freez Plus]SBD1
1729323camphor 0.002 MG/MG / menthol 0.04 MG/MG / methyl salicylate 0.08 MG/MG Topical GelSCD1
1729328Berri-Freez Plus (camphor 0.2 % / menthol 4 % / methyl salicylate 8 % ) Topical GelSY1
1729323camphor 0.2 % / menthol 4 % / methyl salicylate 8 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-008-042020-01-31C16284748780-19d75b9d0-80b9-f424-e053-dadaa90a57ceBerri-Freez Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-008-04Berri-Freez Plus113 g in 1 TUBEGEL1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-008BERRI-FREEZ PLUS (MENTHOL, CAMPHOR, METHYL SALICYLATE) GEL [GERITREX LLC]1Legacy NDC, 1 package rows20160101_3fb70456-c653-4c3d-8a85-fe674da38a9a.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54162-00854162-008-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
METHYL SALICYLATELAV5U5022YACTIB
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANAO80TY208ZWIACT
CALENDULA ARVENSIS LEAF3U3U118F2LIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
THYMECW657OBU4NIACT
TRIETHANOLAMINE BENZOATEM3EN4GC19WIACT
WATER059QF0KO0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML · Source PDF

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
f4751767-ac85-4c8a-a569-f7fbe0bbd2ed3fb70456-c653-4c3d-8a85-fe674da38a9a2012-08-23WarningsExact identifier
spl id: f4751767-ac85-4c8a-a569-f7fbe0bbd2ed
spl set id: 3fb70456-c653-4c3d-8a85-fe674da38a9a

Reported adverse events (FAERS/openFDA)#

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