BIOFREEZE FOOT PAIN RELIEF SET- menthol 
RB Health (US) LLC

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.

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Biofreeze Foot Pain Relief Set

Drug Facts

Active ingredient:

Menthol 10%

Purpose

Pain Relieving Cream

Uses:

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Warnings

For external use only

When using this product:

  • Use only as directed 
  • Avoid contact with the eyes or on mucous membranes 
  • Do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

You experience pain, swelling or blistering of the skin; condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days; arthritic pain persists for more than 10 days, or redness is present

If pregnant or breastfeeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center right away

Directions:

• Adults and Children 12 years of age and older: Rub a thin film over affected areas not more than 3 to 4 times daily;
• Children under 12 years of age: Consult a physician
• wash hands after use with cool water

Inactive ingredients:

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

Questions or comments:

1-800-246-3733

PRINCIPAL DISPLAY PANEL - 85 g Tube Kit

NDC 59316-002-10

BiOFREEZE®
COOL THE PAIN

FOOT PAIN
RELIEF SET

MENTHOL-PAIN
RELIEVING CREAM

FOOT ROLLER intended to
relieve foot pain and pain associated
with plantar fasciitis

1 Biofreeze Foot Cream Tube
Net wt 3 OZ (85 g)
+ 1 Foot Roller

PRINCIPAL DISPLAY PANEL - 85 g Tube Kit
BIOFREEZE FOOT PAIN RELIEF SET 
menthol kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-002
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-002-101 in 1 KIT03/12/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 85 g
Part 1 of 1
BIOFREEZE FOOT CREAM 
menthol cream
Product Information
Item Code (Source)NDC:59316-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-001-1085 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/12/2021
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2022
Document Id: b3a7c30b-7927-46ab-81ae-9fc25ecda859
Set id: 4a885eef-0364-4655-bccc-7158c76cc5b2
Version: 4
Effective Time: 20220223
 
RB Health (US) LLC