BIOFREEZE OVERNIGHT GEL- 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 Overnight Gel

Warnings

For external use only

Flammable: Keep away from excessive heat or open flame

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 •Children 2 years to under 12 years of age:Use only under adult supervision

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, or in conditions affecting children under 12 years of age

If pregnant or breastfeeding:

Ask a health professional before use

Keep out of reach of children:

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

Directions

Directions

¢ adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily

¢ children under 2 years of age: consult a physician

¢ wash hands after use with cool water

Other Info

Other information

¢ store at 20-25°C (68-77°F)

¢ store in a cool dry place away from direct sunlight

Inactive Ingredients

Inactive ingredients

Alcohol, Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer Interpolymer, Fragrance, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melissa Officinalis Leaf Extract, Purified Water, Tocopherol Acetate, Trolamine

Questions or comments? 1-800-246-3733

Drug Facts

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

Uses

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

Active

Active ingredient

Menthol 4% Purpose-Pain Relieving Gel

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Temporarily relieves minor aches and pains of muscles and joints associated with:

¢ simple backache ¢ arthritis ¢ strains ¢ bruises ¢ sprains

NDC 59316-121-10

BiOFREEZE®

GEL

MENTHOL-PAIN
RELIEVING GEL

3 FL OZ 89 mL

Label

BIOFREEZE OVERNIGHT GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALCOHOL (UNII: 3K9958V90M)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59316-121-1089 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2023
Labeler - RB Health (US) LLC (081049410)

Revised: 2/2023
Document Id: f5c8c08b-c7c1-f84d-e053-2a95a90add15
Set id: f5c8c08b-c7c0-f84d-e053-2a95a90add15
Version: 1
Effective Time: 20230228
 
RB Health (US) LLC