Biofreeze Pain Relieving Gel

Manufacturer: Reckitt Benckiser LLC | Span Packaging Services dba Multi-Pack Solutions
Effective date: 2026-05-13
Label type: HUMAN OTC DRUG LABEL
Version: 43
Source: full-release
Hydrated at: 2026-06-01 01:57:22

Label at a glance#

ProductBiofreeze

Active ingredientMENTHOL, UNSPECIFIED FORM

Label structure10 sections

Indications and uses

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

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

Contacts and useful links#

PhoneLabel contact800-246-3733

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol USP 3.5%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Flammable

STORAGE AND HANDLING 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 the 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 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 recur.

If pregnant or breastfeeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of the 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

Other Information:

SPL UNCLASSIFIED SECTION

Store in a cool dry place with lid closed tightly

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water USP

Questions or Comments?

OTC - QUESTIONS SECTION

800-246-3733

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENETRATING, LONG LASTING PAIN RELIEF FROM:
ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®
PAIN RELIEVING Roll-On

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

3 fl oz / 89 mL

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PENETRATING, LONG LASTING PAIN RELIEF FROM:
ARTHITIS • SORE MUSCLES & JOINTS • BACK PAIN

BIOFREEZE ^®
PAIN RELIEVING gel

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ^®

16 fl oz / 473 mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Pump Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1043451	BIOFREEZE 3.5 % Topical Gel	PSN	43
808955	menthol 3.5 % Topical Gel	PSN	43
1043451	menthol 0.035 MG/MG Topical Gel [Biofreeze]	SBD	43
808955	menthol 0.035 MG/MG Topical Gel	SCD	43
1043451	Biofreeze 0.035 MG/MG Topical Gel	SY	43
1043451	Biofreeze 3.5 % Topical Gel	SY	43
808955	menthol 3.5 % Topical Gel	SY	43

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-101-10	Biofreeze	5 mL in 1 PACKET	GEL	5	43
59316-101-11	Biofreeze	30 mL in 1 BOTTLE	GEL	30	43
59316-101-12	Biofreeze	59 mL in 1 TUBE	GEL	59	43
59316-101-13	Biofreeze	59 mL in 1 BOTTLE, WITH APPLICATOR	GEL	59	43
59316-101-15	Biofreeze	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89	43
59316-101-19	Biofreeze	3 mL in 1 PACKET	GEL	3	43
59316-101-20	Biofreeze	118 mL in 1 TUBE	GEL	118	43
59316-101-21	Biofreeze	81 mL in 1 TUBE	GEL	81	43
59316-101-25	Biofreeze	118 mL in 1 TUBE, WITH APPLICATOR	GEL	118	43
59316-101-30	Biofreeze	473 mL in 1 BOTTLE, PUMP	GEL	473	43
59316-101-40	Biofreeze	946 mL in 1 BOTTLE, PUMP	GEL	946	43
59316-101-50	Biofreeze	3785 mL in 1 BOTTLE, PUMP	GEL	3785	43

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	32
Menthol	ACTIVE MOIETY	L7T10EIP3A	32
CAMPHOR (NATURAL)	INACTIVE INGREDIENT	N20HL7Q941	32
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	32
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	32
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	32
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	32
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	32
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	32
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	32
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	32
WATER	INACTIVE INGREDIENT	059QF0KO0R	32

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Biofreeze
Menthol
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GLYCERIN
ISOPROPYL ALCOHOL
METHYLPARABEN
CAMPHOR (NATURAL)
PROPYLENE GLYCOL
SILICON DIOXIDE
TROLAMINE
WATER
MENTHOL, UNSPECIFIED FORM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
59316-101	59316-101-10, 59316-101-15, 59316-101-20, 59316-101-21, 59316-101-30, 59316-101-40, 59316-101-50, 59316-101-25, 59316-101-12, 59316-101-13, 59316-101-11, 59316-101-19

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
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
CAMPHOR (NATURAL)	N20HL7Q941	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TROLAMINE	9O3K93S3TK	IACT
WATER	059QF0KO0R	IACT
MENTHOL, UNSPECIFIED FORM	L7T10EIP3A	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 195 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 39 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 39 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 39 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / TOPICAL		500 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOAP / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LIQUID / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii+route 39 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		75 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
TROLAMINE	TROLAMINE	9O3K93S3TK	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	SHAMPOO / TOPICAL	0.75 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	LOTION / TOPICAL	NA		Exact identifier — unii+route 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii+route+dosage form 13 equally ranked IID candidates
FD&C YELLOW NO. 5	FD&C YELLOW NO. 5	I753WB2F1M	POWDER / TOPICAL	NA		Exact identifier — unii+route 39 equally ranked IID candidates
FD&C BLUE NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CREAM / TOPICAL	0.01 %w/w		Exact identifier — unii+route 78 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biofreeze	MENTHOL	Reckitt Benckiser LLC	684faf63-5e44-4471-8384-e8fa7c0d842a	2026-05-13	Warnings	Exact identifier ndc (package): 59316-101-25 ndc (package): 59316-101-11 ndc (package): 59316-101-10 ndc (package): 59316-101-20 ndc (package): 59316-101-13 ndc (package): 59316-101-19 ndc (package): 59316-101-12 ndc (package): 59316-101-30 ndc (package): 59316-101-40 ndc (package): 59316-101-15 ndc (package): 59316-101-21 ndc (package): 59316-101-50 ndc (product): 59316-101 ndc11 (package): 59316010112 ndc11 (package): 59316010130 ndc11 (package): 59316010120 ndc11 (package): 59316010113 ndc11 (package): 59316010121 ndc11 (package): 59316010115 ndc11 (package): 59316010119 ndc11 (package): 59316010111 ndc11 (package): 59316010150 ndc11 (package): 59316010110 ndc11 (package): 59316010140 ndc11 (package): 59316010125 spl id: 51b434c9-228b-2c05-e063-6394a90a1e94 spl set id: 684faf63-5e44-4471-8384-e8fa7c0d842a

Reported adverse events (FAERS/openFDA)#

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