BIOFREEZE- menthol gel 
RB Health (US) LLC

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Biofreeze Pain Relieving Gel

Active Ingredients

Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Uses

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

Warnings

For external use only.

Flammable

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

When Using This Product

  • 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:

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 the reach of children:

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

Directions

Other Information:

Store in a cool dry place with lid closed tightly

Inactive ingredients

Questions or Comments?

800-246-3733

PRINCIPAL DISPLAY PANEL - 89 mL Bottle Applicator Label

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

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
BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-101-105 mL in 1 PACKET; Type 0: Not a Combination Product08/25/2016
2NDC:59316-101-1589 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
3NDC:59316-101-20118 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
4NDC:59316-101-2181 mL in 1 TUBE; Type 0: Not a Combination Product08/25/201612/31/2018
5NDC:59316-101-30473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
6NDC:59316-101-40946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
7NDC:59316-101-503785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/25/2016
8NDC:59316-101-25118 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/201612/31/2021
9NDC:59316-101-1259 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2016
10NDC:59316-101-1359 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product08/25/2016
11NDC:59316-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product08/25/2016
12NDC:59316-101-193 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/25/2016
Labeler - RB Health (US) LLC (081049410)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services dba Multi-Pack Solutions557434805manufacture(59316-101)

Revised: 12/2024
Document Id: 2a4622c1-eef8-28e2-e063-6294a90abbfa
Set id: 684faf63-5e44-4471-8384-e8fa7c0d842a
Version: 42
Effective Time: 20241227
 
RB Health (US) LLC