Biotemper

Label

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

Label

BIOTEMPER
menthol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - SSG Ventures Inc (047626115)

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