BLUE ICE ANALGESIC GEL- menthol gel 
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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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Drug Facts

Active Ingredient


Menthol 2.0%

Uses

Directions

Directions:

Warnings

When using this product, do not:

To do so may result in excessive skin irritation or skin burn.

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. If you have sensitive skin consult a physician. If skin irritation develops, discontinue use and seek the advice of a physician before using this product.

SB Blue Ice Gel

Purpose

INACTIVE INGREDIENTS

INACTIVE INGREDIENTS: WATER, ISOPROPYL ALCOHOL, CARBOMER, THYMOL, AMMONIUM HYDROXIDE, SODIUM HYDROXIDE, MAGNESIUM SULFATE, FD&C BLUE 1.

Keep out of reach of children

BLUE ICE ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-452
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 88.05 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302) 8.91 g  in 100 g
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.667 g  in 100 g
THYMOL (UNII: 3J50XA376E) 0.2 g  in 100 g
AMMONIA (UNII: 5138Q19F1X) 0.06 g  in 100 g
SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.1 g  in 100 g
MAGNESIUM SULFATE (UNII: DE08037SAB) 0.01 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 0.003 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15127-452-08227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/06/2014
Labeler - Select Brand Distributors (043562370)
Establishment
NameAddressID/FEIBusiness Operations
Delon Laboratories (1990) Ltd243387722label(15127-452) , manufacture(15127-452) , pack(15127-452)

Revised: 10/2014
Document Id: 6e4a05c3-0277-4e40-a943-b15d0a549620
Set id: 96c97f28-ef22-4554-8a9e-0447c427e909
Version: 3
Effective Time: 20141007
 
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