FDA.reportPublic FDA data

Biofreeze Roll-On

Manufacturer
REMEDYREPACK INC.
Effective date
2019-02-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:30:51

Label at a glance#

ProductBiofreeze Roll-On
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

Temporary relief from minor aches and pains of sore muscles and joints associated with:  - arthritis, - backache,  - strains, - sprains

Dosage and administration

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary Children under 2 years of age: Consult physician

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 4%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses:

INDICATIONS & USAGE SECTION

Temporary relief from minor aches and pains of sore muscles and joints associated with:  - arthritis, - backache,  - strains, - sprains

Warnings:

WARNINGS SECTION

For external use only

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Sensitive skin

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin.
  • Do not use with other ointments, creams, sprays, or liniments.
  • Do not apply to irritated skin or if excessive skin 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:

OTC - STOP USE SECTION

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 2 years of age: Consult physician

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carteril Resin Extract, Calendula Officinallis Extract, Carbomer, Camellia Sinensis (Green Tea) Leaf Extract, Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Ispropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

Other Information:

SPL UNCLASSIFIED SECTION

Store in a cool dry place with lid closed tightly

Questions or Comments

OTC - QUESTIONS SECTION

1-800-246-3733

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Biofreeze Roll-On

GENERIC: MENTHOL

DOSAGE: GEL

ADMINSTRATION: TOPICAL

NDC: 70518-0068-0

PACKAGING: 89 mL in 1 BOTTLE, WITH APPLICATOR

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • MENTHOL 40mg in 1mL

INACTIVE INGREDIENT(S):

  • ARNICA MONTANA FLOWER
  • GREEN TEA LEAF
  • CALENDULA OFFICINALIS FLOWER
  • GLYCERIN
  • FRANKINCENSE
  • ISOPROPYL MYRISTATE
  • ILEX PARAGUARIENSIS LEAF
  • ISOPROPYL ALCOHOL
  • .ALPHA.-TOCOPHEROL ACETATE
  • TROLAMINE
  • FD&C BLUE NO. 1
  • WATER
  • ALOE VERA LEAF
  • FD&C YELLOW NO. 5
  • MELISSA OFFICINALIS LEAF
  • SILICON DIOXIDE

Remedy_LabelRemedy_Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59316-205-10ML - Milliliter59316-20514d40e2b-5615-41bd-a594-c7c596c2427b12024-06-10
59316-205-14ML - Milliliter59316-205cd2e340d-0c11-4803-a4f5-ecfbd7e195ce12022-09-12

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-006870518-0068-0
59316-205

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
FRANKINCENSER9XLF1R1WMIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
GLYCERINPDC6A3C0OXIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
MENTHOLL7T10EIP3AACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
ndc (product): 59316-205
984ea53d-ca1a-c2bd-e053-2a95a90a74ee6fdd10ef-0a42-4908-9f44-89053f1aa1c32019-11-27WarningsExact identifier
spl set id: 6fdd10ef-0a42-4908-9f44-89053f1aa1c3

Reported adverse events (FAERS/openFDA)#

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