BL3 MINERAL ICE GEL- menthol gel

BL3 Mineral Ice Gel by

Drug Labeling and Warnings

BL3 Mineral Ice Gel by is a Otc medication manufactured, distributed, or labeled by Inspec Solutions, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Menthol 2%

PURPOSE

Menthol 2% .........................Analgesic

INDICATIONS & USAGE

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises and sprains.

WARNINGS

Warnings

For external use only

sue only as directed

avoid contact with eyes

do not bandage tightly

do not apply to wounds or damaged skin

​ do not use with heating pad

STOP USE

Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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.

DOSAGE & ADMINISTRATION

Direction

For adult & children 2 years of age and older

Cleans ad dry skin

Apply to affected area not more than 3 to 4 times daily

may be used with wet or dry bandages in conjunction with ice packs

children under 2 years of age, consult a doctor

INACTIVE INGREDIENT

Inactive Ingredients Ammonium Hydroxide, Carbomer, Cupric Sulfate, FD&C Blue No. 1, Isopropyl Alcohol, Magnesium Sulfate, Sodium Hydroxide, Thymol, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BL3 MINERAL ICE GEL 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72667-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
THYMOL (UNII: 3J50XA376E)
CARBOMER 1342 (UNII: 809Y72KV36)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TETRAETHYLAMMONIUM HYDROXIDE HEXAHYDRATE (UNII: 2GBD78DRH6)
CUPRIC SULFATE ANHYDROUS (UNII: KUW2Q3U1VV)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72667-013-01	227 g in 1 JAR; Type 0: Not a Combination Product	06/12/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	06/12/2019

Labeler - Inspec Solutions, LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions, LLC.		081030372	manufacture(72667-013)