BL3 MINERAL ICE GEL- menthol gel 
Inspec Solutions, 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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THERAPEUTIC MENTHOL GEL

Active Ingredient

Menthol 2%

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

Uses

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

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 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. If swallowed, get medical help or contact a Poison Control Center right away.

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

BL3 Ice Gel

BL3 MINERAL ICE GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-013-01227 g in 1 JAR; Type 0: Not a Combination Product06/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34606/12/2019
Labeler - Inspec Solutions, LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions, LLC.081030372manufacture(72667-013)

Revised: 6/2019
 
Inspec Solutions, LLC.