BIOTEMPER- menthol gel BIOTEMPER FOOT CREAM- menthol gel

Biotemper Foot Cream by

Drug Labeling and Warnings

Biotemper Foot Cream by is a Otc medication manufactured, distributed, or labeled by SSG Ventures Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Menthol 10%.......................Topical Analgesic

TOPICAL ANALGESIC WITH 10% MENTHOL

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

FAST ACTING COOLING PAIN RELIEF

FOR EXTERNAL USE ONLY

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. 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIOTEMPER 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81376-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81376-001-01	113 mL in 1 JAR; Type 0: Not a Combination Product	01/01/2021
2	NDC: 81376-001-02	452 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2021
3	NDC: 81376-001-03	1900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/01/2021
4	NDC: 81376-001-04	89 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2021
5	NDC: 81376-001-05	118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	01/01/2021
6	NDC: 81376-001-06	118 mL in 1 TUBE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2021

BIOTEMPER FOOT CREAM 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81376-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
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)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Product Characteristics
Color	white (Opaque)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81376-002-01	57 mL in 1 JAR; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2021

Labeler - SSG Ventures Inc (047626115)

Establishment
Name	Address	ID/FEI	Business Operations
SSG Ventures Inc		047626115	manufacture(81376-001, 81376-002)