BIO-RELIEF- menthol gel 
BIO-RELIEF H- menthol gel 
SSG Ventures Inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Bio-Relief

Label

Menthol 10%.

Purpose: Topical Analgesic

COOLING GEL W 10% MENTHOL IN ARNICA TINCTURE

FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN

FAST ACTING COOLING PAIN RELIEF

FOR EXTERNAL USE ONLY

FLAMMABLE, KEEP AWAY FROM FLAME

KEEP OUT OF REACH OF CHILDREN.

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY

Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.

Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.

Store in a cool and dry place with lid closed tightly.

Label

BIO-RELIEF 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ARNICA MONTANA (UNII: O80TY208ZW)  
THYMOL (UNII: 3J50XA376E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TEA TREE OIL (UNII: VIF565UC2G)  
BOSWELLIA SACRA BARK (UNII: 1UK28DX728)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Product Characteristics
Colorwhite (Opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81376-003-0189 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2021
BIO-RELIEF H 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 10 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
THYMOL (UNII: 3J50XA376E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
Product Characteristics
Colorwhite (Opaque) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81376-004-0189 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2021
Labeler - SSG Ventures Inc (047626115)
Establishment
NameAddressID/FEIBusiness Operations
SSG Ventures Inc047626115manufacture(81376-003, 81376-004)

Revised: 4/2021
Document Id: c081dbd9-1729-6070-e053-2995a90a28e8
Set id: c081f351-324c-cb7e-e053-2a95a90ae660
Version: 2
Effective Time: 20210421
 
SSG Ventures Inc