BIOTEMPER by Scientific Solutions Global, LLC BIOTEMPER- menthol gel

BIOTEMPER by

Drug Labeling and Warnings

BIOTEMPER by is a Otc medication manufactured, distributed, or labeled by Scientific Solutions Global, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BIOTEMPER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71718-333
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71718-333-01	118 mL in 1 JAR; Type 0: Not a Combination Product	09/01/2017
2	NDC: 71718-333-02	2 in 1 PACKAGE	09/01/2017
2		118 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 71718-333-04	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2017
4	NDC: 71718-333-05	2 in 1 PACKAGE	09/01/2017
4		118 mL in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 71718-333-07	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2017
6	NDC: 71718-333-09	452 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2017
7	NDC: 71718-333-11	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2017
8	NDC: 71718-333-13	1893 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2017
9	NDC: 71718-333-15	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2017

Labeler - Scientific Solutions Global, LLC (097291290)

Establishment
Name	Address	ID/FEI	Business Operations
Scientific Solutions Global, LLC		097291290	manufacture(71718-333)