BIOFREEZE- menthol cream 
RB Health (US) LLC

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Biofreeze Overnight Relief Cream

Drug Facts

Active Ingredients:

Menthol USP 10%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with: • arthritis • 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:

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

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 immediately

Directions:


■ adults and children 12 years of age and older: rub a thin film over affected area 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:


Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,
Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,
Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,
Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,
PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate

Questions or Comments:

1-800-246-3733

Package Labeling:

Label

BIOFREEZE 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-870
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
ALCOHOL (UNII: 3K9958V90M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
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:59316-870-1085 g in 1 JAR; Type 0: Not a Combination Product02/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01702/15/2024
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2024
Document Id: 10a8face-47db-ebbe-e063-6294a90a42fe
Set id: 10a8face-47da-ebbe-e063-6294a90a42fe
Version: 7
Effective Time: 20240202
 
RB Health (US) LLC