BIOFREEZE- menthol gel 
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 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 not finalpart34808/25/2016
Labeler - RB Health (US) LLC (081049410)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services dba Multi-Pack Solutions117101131manufacture(59316-101)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services dba Multi-Pack Solutions557434805manufacture(59316-101)

Revised: 2/2022
Document Id: b884afb9-3926-4096-b881-e78633f4033e
Set id: 684faf63-5e44-4471-8384-e8fa7c0d842a
Version: 41
Effective Time: 20220224
 
RB Health (US) LLC