BIOTEMPER- menthol gel 
Scientific Solutions Global, 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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BIOTEMPER

Drug Facts

Active Ingredient

Menthol 10%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains

Warnings

For external use only
Flammable keep away from fire or flame
When using this product • avoid contact with eyes or mucous membranes • do not bandage tightly • do not apply to wound or damaged or irritated skin
Stop use and consult a doctor if • condition worsens • symptoms persist for more than 7 days • clear up and occur again within a few days
If pregnant or breast-feeding, 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

• Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily • Children under 2 years of age, consult a physician • Massage not necessary • Shake well before use

Inactive Ingredients

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

Other Information

• store in a cool and dry place with lid closed tightly

Questions or Comments?

Call us at: 1(516) 543-3376 M-F 9am-6pm EST or E-mail:info@biotemper.com

DEEP PENETRATING GEL

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

MADE WITH HERBAL & HOMEOPATHIC INGREDIENTS

NO NSAIDs, IBUPROFEN, ASPIRIN, OR SALICYLATE

BIOTEMPER.COM

DISTRIBUTED BY:

SCIENTIFIC SOLUTIONS GLOBAL, LLC

CARLE PLACE, NY

PROUDLY MADE IN USA

Packaging

BioTGel1BioTGel2

BIOTEMPER 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71718-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
FRANKINCENSE (UNII: R9XLF1R1WM)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TEA TREE OIL (UNII: VIF565UC2G)  
THYMOL (UNII: 3J50XA376E)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71718-333-01118 mL in 1 JAR; Type 0: Not a Combination Product09/01/2017
2NDC:71718-333-022 in 1 PACKAGE09/01/2017
2118 mL in 1 JAR; Type 0: Not a Combination Product
3NDC:71718-333-04118 mL in 1 TUBE; Type 0: Not a Combination Product09/01/2017
4NDC:71718-333-052 in 1 PACKAGE09/01/2017
4118 mL in 1 TUBE; Type 0: Not a Combination Product
5NDC:71718-333-07237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2017
6NDC:71718-333-09452 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2017
7NDC:71718-333-11946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2017
8NDC:71718-333-131893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2017
9NDC:71718-333-153785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/2017
Labeler - Scientific Solutions Global, LLC (097291290)
Establishment
NameAddressID/FEIBusiness Operations
Scientific Solutions Global, LLC097291290manufacture(71718-333)

Revised: 1/2018
Document Id: 158b958a-1a99-4f82-931b-c5c83e320ad2
Set id: 667fb0b9-6095-4c6c-8731-a4f888951ecc
Version: 1
Effective Time: 20180129
 
Scientific Solutions Global, LLC