BIOFREEZE- menthol spray 
RB Health (US) LLC

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Biofreeze Pain Relieving Spray

Drug Facts

Active Ingredients:

Menthol USP 10%

Purpose

Cooling Pain Reliever

Uses:

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

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 damages 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 reoccur

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:Spray on to the affected areas not more than 4 times daily; massage not necessary.

Children under 12 years of age:Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea, Ethanol,  ilex Paraguarenis, Isopropyl Myristate, Juniper Berry, water, White Tea

Questions or Comments?

1-800-246-3733

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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

BIOFREEZE ®
PAIN RELIEVING Spray

WITH SOOTHING MENTHOL

Cryotherapy - The Cold Method ®

16 fl. oz./473mL

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
BIOFREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-104
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 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA WHOLE (UNII: O80TY208ZW)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
CHAMOMILE (UNII: FGL3685T2X)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
ALCOHOL (UNII: 3K9958V90M)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
JUNIPERUS COMMUNIS WHOLE (UNII: 464910T5N9)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-104-1059 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
2NDC:59316-104-20118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
3NDC:59316-104-30473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/25/2016
4NDC:59316-104-25118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/29/201212/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/01/2010
Labeler - RB Health (US) LLC (081049410)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging services LLC dba Multi-Pack Solutions117101131manufacture(59316-104)
Establishment
NameAddressID/FEIBusiness Operations
Span Packaging Services LLC dba Multi-Pack Solutions557434805manufacture(59316-104)

Revised: 1/2024
Document Id: 0e77224c-d682-ad31-e063-6294a90a9032
Set id: 5edddb99-6596-4a3b-b361-1cc04d032c31
Version: 38
Effective Time: 20240108
 
RB Health (US) LLC